General description of the Amendments to Article 7 and to
the Annex to Article 4 of the “Regulations Governing the
Classification of Medical Devices”
As medical devices involve a variety of scientific fields, their types, items, and
compositions are complex and rapidly changing. To clarify the scope of medical
device subject to management, we have reviewed the contents of the Annex to Article
4 of the "Regulations Governing the Classification of Medical Devices" and made
appropriate revisions based on international management approaches and the current
situation.
It is recognized that medical device firms should be given a grace period to respond to
the amendments, and the Article 7 and the Annex to Article 4 have been amended
accordingly. The amendments are as follows:
1.The date of entering into force of the new product items in Article 4. (Amendment
to Article 7)
2.63 product items have been added. (Amendment to the Annex to Article 4)Article 7 Amendment Comparison Table
Amend Article Current Article Description
Article 7
The Regulations shall
enter into force on May 1,
2021, excluding
classification numbers
“A.3652”, “C.3372”, and
“C.3970” from the Annex
which shall be effective on
July 1, 2022.
The amendments to the
Annex to Article 4 shall
enter into force on August
22, 2023, excluding
classification numbers
“D.1100”, “J.5780”, and
“M.5844” from the Annex
which shall be effective on
August 22, 2025 and
classification number
“I.4040” from the Annex
which shall be effective on
August 22, 2026.Article 7
The Regulations shall
enter into force on May 1,
2021, excluding
classification numbers
“A.3652”, “C.3372”, and
“C.3970” from the Annex
which shall be effective on
July 1, 2022.Since the classification
numbers “D.1100”, “J.5780”,
“M.5844”, and “I.4040”
involve classification changes
or new mandatory standards,
the above-mentioned
classification numbers are set
with dates of entering into
force to facilitate medical
device firms to comply with
the “Medical Devices Act”
during the grace period.1Comparison Table
Amendment to the Annex to Article 4
Amendments Current regulations
Explanation classifi
cation
numberEnglish nameClas
sIdentificationclassifi
cation
numberEnglish name Class Identification
A.1040 Aldolase test
system1 An aldolase test system is
a device intended to
measure the activity of the
enzyme aldolase in serum
or plasma. Aldolase
measurements are used in
the diagnosis and
treatment of the early
stages of acute hepatitis
and for certain muscle
diseases such as
progressive Duchenne-
type muscular dystrophy.A.1040 Aldolase test
system1 An aldolase test system is a
device intended to measure
the activity of the enzyme
aldolase in serum or plasma.
Aldolase measurements are
used in the diagnosis and
treatment of the early stages
of acute hepatitis and for
certain muscle diseases such
as progressive Duchenne-
type muscular dystrophy.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.1045 Aldosterone test
system2 An aldosterone test system
is a device designed for
the measurement of
aldosterone hormoneA.1045 Aldosterone test
system2 An aldosterone test system
is a device intended to
measure the hormone
aldosterone in serum and1.Amend the
Chinese name
and the wording2concentrations in serum
and urine. Aldosterone
measurements are used in
the diagnosis and
treatment of primary
aldosteronism (a disorder
caused by the excessive
secretion of aldosterone by
the adrenal gland),
hypertension caused by
primary aldosteronism,
selective
hypoaldosteronism,
edematous states, and
other conditions of
electrolyte imbalance.urine. Aldosterone
measurements are used in
the diagnosis and treatment
of primary aldosteronism (a
disorder caused by the
excessive secretion of
aldosterone by the adrenal
gland), hypertension caused
by primary aldosteronism,
selective
hypoaldosteronism,
edematous states, and other
conditions of electrolyte
imbalance.in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.1075 Androstenedione
test system1 An androstenedione test
system is a device
intended to measure
androstenedione (a
substance secreted by the
testes, ovary, and adrenal
glands) in serum.
Androstenedione
measurements are used in
the diagnosis and
treatment of females with
excessive levels of
androgen (male sex
hormone) production.A.1075 Androstenedione
test system1 An androstenedione test
system is a device intended
to measure androstenedione
(a substance secreted by the
testes, ovary, and adrenal
glands) in serum.
Androstenedione
measurements are used in
the diagnosis and treatment
of females with excessive
levels of androgen (male sex
hormone) production.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the3advice of
experts.
A.1355 Integrated
continuous glucose
monitoring system2,3 An integrated continuous
glucose monitoring system
(iCGM) is intended to
automatically measure
glucose in bodily fluids
continuously or frequently
for a specified period of
time.
Classification: (1) Class 2
devices are intended to be
used alone for diabetes
self-management. (2)
Class 3 devices are
intended to transmit
glucose measurement data
to automated insulin
dosing systems, and to
adjust insulin dose.1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
management of
our country, the
new product
item is divided
into class 2 and
3.
A.1390 5-Hydroxyindole
acetic
acid/serotonin test
system1 A 5-hydroxyindole acetic
acid/serotonin test system
is a device intended to
measure 5-hydroxyindole
acetic acid/serotonin in
urine.
Measurements of 5-
hydroxyindole acetic
acid/serotonin are used in
the diagnosis andA.1390 5-Hydroxyindole
acetic
acid/serotonin test
system1 A 5-hydroxyindole acetic
acid/serotonin test system is
a device intended to
measure 5-hydroxyindole
acetic acid/serotonin in
urine.
Measurements of 5-
hydroxyindole acetic
acid/serotonin are used in
the diagnosis and treatment1.Amend the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational4treatment of carcinoid
tumors of endocrine tissue.of carcinoid tumors of
endocrine tissue.Research and the
advice of
experts.
A.1655 Pyruvic acid test
system1 A pyruvic acid test system
is a device intended to
measure pyruvic acid (an
intermediate compound in
the metabolism of
carbohydrate) in plasma.
Measurements obtained by
this device are used in the
evaluation of electrolyte
metabolism, and in the
diagnosis and treatment of
acid-base and electrolyte
disturbances or anoxia (the
reduction of oxygen in
body tissues).A.1655 Pyruvic acid test
system1 A pyruvic acid test system
is a device intended to
measure pyruvic acid (an
intermediate compound in
the metabolism of
carbohydrate) in plasma.
Measurements obtained by
this device are used in the
evaluation of electrolyte
metabolism and in the
diagnosis and treatment of
electrolyte disturbances or
anoxia (the reduction of
oxygen in body tissues).1.Amend the
wording in the
identification.
A.1680 Testosterone test
system1 A testosterone test system
is a device intended to
measure testosterone (a
male sex hormone) in
serum, plasma, and urine.
Measurement of
testosterone are used in the
diagnosis and treatment of
disorders involving the
male sex hormones
(androgens), including
primary and secondaryA.1680 Testosterone test
system1 A testosterone test system is
a device intended to
measure testosterone (a
male sex hormone) in
serum, plasma, and urine.
Measurement of
testosterone are used in the
diagnosis and treatment of
disorders involving the male
sex hormones (androgens),
including primary and
secondary hypogonadism,1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for5hypogonadism, delayed or
precocious puberty,
impotence in male’s and,
in female’s hirsutism
(excessive hair) and
virilization
(masculinization) due to
tumors, polycystic ovaries,
and adrenogenital
syndromes.delayed or precocious
puberty, impotence in
male’s and, in female’s
hirsutism (excessive hair)
and virilization
(masculinization) due to
tumors, polycystic ovaries,
and adrenogenital
syndromes.Educational
Research and the
advice of
experts.
A.2270 Thin-layer
chromatography
system for clinical
use1 A thin-layer
chromatography (TLC)
system for clinical use is a
device intended to separate
one or more drugs or
compounds from a
mixture. The mixture of
compounds is absorbed
onto a stationary phase or
thin layer of inert material
(e.g., cellulose, alumina,
etc.) and eluted off by a
moving solvent (moving
phase) until equilibrium
occurs between the two
phases.A.2270 Thin-layer
chromatography
system for clinical
us1 A thin-layer
chromatography (TLC)
system for clinical use is a
device intended to separate
one or more drugs or
compounds from a mixture.
The mixture of compounds
is absorbed onto a stationary
phase or thin layer of inert
material (e.g., cellulose,
alumina, etc.) and eluted off
by a moving solvent
(moving phase) until
equilibrium occurs between
the two phases.1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.6A.3050 Breath- alcohol test
system1 A breath-alcohol test
system is a device
intended to measure
alcohol in the human
breath. Measurements
obtained by this device are
used in the diagnosis of
alcohol intoxication.A.3050 Breath-alcohol
test system1 A breath-alcohol test system
is a device intended to
measure alcohol in the
human breath.
Measurements obtained by
this device are used in the
diagnosis of alcohol
intoxication.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.3380 Ethosuximide test
system2 An ethosuximide test
system is a device
intended to measure
ethosuximide
concentrations, an
antiepileptic drug, in
human specimens.
Measurements obtained by
this device are used in the
diagnosis and treatment of
ethosuximide overdose
and in monitoring levels of
ethosuximide to ensure
appropriate therapy.A.3380 Ethosuximide test
system2 An ethosuximide test
system is a device intended
to measure ethosuximide, an
antiepileptic drug, in human
specimens.
Measurements obtained by
this device are used in the
diagnosis and treatment of
ethosuximide overdose and
in monitoring levels of
ethosuximide to ensure
appropriate therapy.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the7advice of
experts.
A.3555 Lidocaine test
system2 A lidocaine test system is
a device intended to
measure lidocaine, an
antiarrhythmic and
anticonvulsant drug, in
serum and plasma.
Measurements obtained by
this device are used in the
diagnosis and treatment of
lidocaine overdose or in
monitoring levels of
lidocaine to ensure
appropriate therapy.A.3555 Lidocaine test
system2 A lidocaine test system is a
device intended to measure
lidocaine, an antiarrhythmic
and anticonvulsant drug, in
serum and plasma.
Measurements obtained by
this device are used in the
diagnosis and treatment of
lidocaine overdose or in
monitoring levels of
lidocaine to ensure
appropriate therapy.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.3560 Lithium test system 2 A lithium test system is a
device intended to measure
the concentration of
lithium (from the drug
lithium carbonate) in
serum or plasma.
Measurements of lithium
are used to assure that the
proper drug dosage is
administered in the
treatment of patients with
mental disturbances, suchA.3560 Lithium test
system2 A lithium test system is a
device intended to measure
lithium (from the drug
lithium carbonate) in serum
or plasma. Measurements of
lithium are used to assure
that the proper drug dosage
is administered in the
treatment of patients with
mental disturbances, such as
manic-depressive illness
(bipolar disorder).1.Amend the
Chinese wording
in the
identification.
2.Remove
inappropriate
text.8as manic-depressive
illness.
A.3580 Lysergic acid
diethylamide
(LSD) test system2 A lysergic acid
diethylamide (LSD) test
system is a device
intended to measure
lysergic acid diethylamide
concentrations, a
hallucinogenic drug, in
serum, urine, and gastric
contents. Measurements
obtained by this device are
used in the diagnosis and
treatment of LSD use or
overdose.A.3580 Lysergic acid
diethylamide
(LSD) test system2 A lysergic acid
diethylamide (LSD) test
system is a device intended
to measure lysergic acid
diethylamide, a
hallucinogenic drug, in
serum, urine, and gastric
contents. Measurements
obtained by this device are
used in the diagnosis and
treatment of LSD use or
overdose.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.3630 Methaqualone test
system2 A methaqualone test
system is a device
intended to measure
methaqualone, a hypnotic
and sedative drug, in urine.
Measurements obtained by
this device are used in the
diagnosis and treatment ofA.3630 Methaqualone test
system2 A methaqualone test system
is a device intended to
measure methaqualone, a
hypnotic and sedative drug,
in urine. Measurements
obtained by this device are
used in the diagnosis and
treatment of methaqualone
use or overdose.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms9methaqualone use or
overdose.from the
National
Academy for
Educational
Research and the
advice of
experts.
A.3645 Neuroleptic drugs
radioreceptor assay
test system2 A neuroleptic drugs
radioceptor assay test
system is a device
intended to measure in
serum or plasma the
dopamine receptor
blocking activity of
neuroleptic drugs and their
active metabolites.
A neuroleptic drug has
anti-psychotic action
affecting principally
psychomotor activity, is
generally without hypnotic
effects, and is a
tranquilizer.
Measurements obtained by
this device are used to aid
in determining whether a
patient is taking the
prescribed dosage level of
such drugs.A.3645 Neuroleptic drugs
radioreceptor
assay test system2 A neuroleptic drugs
radioceptor assay test
system is a device intended
to measure in serum or
plasma the dopamine
receptor blocking activity of
neuroleptic drugs and their
active metabolites.
A neuroleptic drug has anti-
psychotic action affecting
principally psychomotor
activity, is generally without
hypnotic effects, and is a
tranquilizer. Measurements
obtained by this device are
used to aid in determining
whether a patient is taking
the prescribed dosage level
of such drugs.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.10A.3670 Phenothiazine test
system2 A phenothiazine test
system is a device
intended to measure any of
the drugs of the
phenothiazine class in
human specimens.
Measurements obtained by
this device are used in the
diagnosis and treatment of
phenothiazine use or
overdose.A.3670 Phenothiazine test
system2 A phenothiazine test system
is a device intended to
measure any of the drugs of
the phenothiazine class in
human specimens.
Measurements obtained by
this device are used in the
diagnosis and treatment of
phenothiazine use or
overdose.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
A.3870 Cannabinoid test
system2 A cannabinoid test system
is a device intended to
measure any of the
cannabinoids,
hallucinogenic compounds
endogenous to marihuana,
in serum, plasma, saliva,
and urine. Cannabinoid
compounds include delta-
9-tetrahydrocannabinol,
cannabidiol, cannabinol,
and cannabichromene.
Measurements obtained by
this device are used in the
diagnosis and treatment ofA.3870 Cannabinoid test
system2 A cannabinoid test system is
a device intended to
measure any of the
cannabinoids,
hallucinogenic compounds
endogenous to marihuana,
in serum, plasma, saliva,
and urine. Cannabinoid
compounds include delta-9-
tetrahydrocannabinol,
cannabidiol, cannabinol, and
cannabichromene.
Measurements obtained by
this device are used in the
diagnosis and treatment of1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the11cannabinoid use or abuse
and in monitoring levels of
cannabinoids during
clinical investigational
use.cannabinoid use or abuse
and in monitoring levels of
cannabinoids during clinical
investigational use.advice of
experts.
A.3880 Theophylline test
system2 A theophylline test system
is a device intended to
measure theophylline (a
drug used for stimulation
of the muscles in the
cardiovascular, respiratory,
and central nervous
systems) in serum and
plasma. Measurements
obtained by this device are
used in the diagnosis and
treatment of theophylline
overdose or in monitoring
levels of theophylline to
ensure appropriate therapy.A.3880 Theophylline test
system2 A theophylline test system
is a device intended to
measure theophylline (a
drug used for stimulation of
the muscles in the
cardiovascular, respiratory,
and central nervous
systems) in serum and
plasma. Measurements
obtained by this device are
used in the diagnosis and
treatment of theophylline
overdose or in monitoring
levels of theophylline to
ensure appropriate therapy.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.3700 Whole slide
imaging system2 The whole slide imaging
system is an automated
digital slide creation,
viewing, and management
system intended as an aid
to the pathologist to
review and interpret digital
images of pathology
slides.B.3700 Whole slide
imaging system.2 The whole slide imaging
system is an automated
digital slide creation,
viewing, and management
system intended as an aid to
the pathologist to review
and interpret digital images
of surgical pathology slides.1.Amend the
wording in the
identification.
2.Delete the word
"surgical " to
conform to the
current
management
model.12B.5200 Automated cell
counter2 An automated cell counter
is a fully-automated or
semi-automated device
used to count red blood
cells, white blood cells, or
blood platelets using a
sample of the patient's
peripheral blood (blood
circulating in one of the
body's extremities, such as
the arm). These devices
may also measure
hemoglobin or hematocrit
and may also calculate or
measure one or more of
the red cell indices (the
erythrocyte mean
corpuscular volume, the
mean corpuscular
hemoglobin, or the mean
corpuscular hemoglobin
concentration). These
devices may use either an
electronic particle
counting method or an
optical counting method.B.5200 Automated cell
counter2 An automated cell counte r is
a fully-automated or semi-
automated device used to
count red blood cells, white
blood cells, or blood
platelets using a sample of
the patient's peripheral
blood (blood circulating in
one of the body's
extremities, such as the
arm). These devices may
also measure hemoglobin or
hematocrit and may also
calculate or measure one or
more of the red cell indices
(the erythrocyte mean
corpuscular volume, the
mean corpuscular
hemoglobin, or the mean
corpuscular hemoglobin
concentration). These
devices may use either an
electronic particle counting
method or an optical
counting method.1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.5300 Red cell indices
device2 A red cell indices device,
usually part of a larger
system, calculates or
directly measures the
erythrocyte meanB.5300 Red cell indices
device2 A red cell indices device,
usually part of a larger
system, calculates or
directly measures the
erythrocyte mean1.Amend the
Chinese wording
in the
identification.13corpuscular volume
(MCV), the mean
corpuscular hemoglobin
(MCH), and the mean
corpuscular hemoglobin
concentration (MCHC).
The red cell indices are
used for the differential
diagnosis of anemias.corpuscular volume (MCV),
the mean corpuscular
hemoglobin (MCH), and the
mean corpuscular
hemoglobin concentration
(MCHC). The red cell
indices are used for the
differential diagnosis of
anemias.2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.5600 Automated
hematocrit
instrument2 An automated hematocrit
instrument is a fully
automated or semi-
automated device which
may or may not be part of
a larger system. This
device measures the
packed red cell volume of
a blood sample to
distinguish normal from
abnormal states, such as
anemia and erythrocytosis
(an increase in the number
of red cells).B.5600 Automated
hematocrit
instrument2 An automated hematocrit
instrument is a fully
automated or semi-
automated device which
may or may not be part of a
larger system. This device
measures the packed red cell
volume of a blood sample to
distinguish normal from
abnormal states, such as
anemia and erythrocytosis
(an increase in the number
of red cells).1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.7440 Electrophoretic
hemoglobin
analysis system2 A hemoglobin
electrophoresis analysis
system is a device thatB.7440 Electrophoretic
hemoglobin
analysis system2 An electrophoretic
hemoglobin analysis system
is a device that1.Amend the
Chinese name
and the wording14electrophoretically
separates and identifies
normal and abnormal
hemoglobin types as an aid
in the auxiliary diagnosis
of anemia or
erythrocytosis (increased
total red cell mass) due to
a hemoglobin abnormality.electrophoretically separates
and identifies normal and
abnormal hemoglobin types
as an aid in the diagnosis of
anemia or erythrocytosis
(increased total red cell
mass) due to a hemoglobin
abnormality.in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.7735 Prothrombin-
proconvertin test
and thrombotest2 The prothrombin-
proconvertin test and
thrombotest are devices
used in the regulation of
coumarin therapy
(administration of a
coumarin anticoagulant
such as sodium warfarin in
the treatment of venous
thrombosis and pulmonary
embolism) and as a
diagnostic test in
conjunction with, or in
place of, the Quick
prothrombin time test to
detect coagulation
disorders.B.7735 Prothrombin-
proconvertin test
and thrombotest2 The prothrombin-
proconvertin test and
thrombotest are devices
used in the regulation of
coumarin therapy
(administration of a
coumarin anticoagulant such
as sodium warfarin in the
treatment of venous
thrombosis and pulmonary
embolism) and as a
diagnostic test in
conjunction with, or in place
of, the Quick prothrombin
time test to detect
coagulation disorders.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.15B.7750 Prothrombin time
test2 A prothrombin time test is
a device used as a general
screening procedure for
the detection of possible
clotting factor deficiencies
in the extrinsic coagulation
pathway, which involves
the reaction between
coagulation factors III and
VII, and to monitor
patients receiving
coumarin therapy (the
administration of one of
the coumarin
anticoagulants in the
treatment of venous
thrombosis or pulmonary
embolism).B.7750 Prothrombin time
test2 A prothrombin time test is a
device used as a general
screening procedure for the
detection of possible
clotting factor deficiencies
in the extrinsic coagulation
pathway, which involves the
reaction between
coagulation factors III and
VII, and to monitor patients
receiving coumarin therapy
(the administration of one of
the coumarin anticoagulants
in the treatment of venous
thrombosis or pulmonary
embolism).1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.7875 Thrombin time test 2 A thrombin time test is a
device used to measure
fibrinogen concentration
and detect fibrin or
fibrinogen split products
for the evaluation of
bleeding disorders.B.7875 Thrombin time
test2 A thrombin time test is a
device used to measure
fibrinogen concentration and
detect fibrin or fibrinogen
split products for the
evaluation of bleeding
disorders.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational16Research and the
advice of
experts.
B.7900 Thromboplastin
generation test1 A thromboplastin
generation test is a device
used to detect and identify
coagulation factor
deficiencies and
coagulation inhibitors.B.7900 Thromboplastin
generation test1 A thromboplastin generation
testis a device used to detect
and identify coagulation
factor deficiencies and
coagulation inhibitors.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.7925 Partial
thromboplastin
time tests2 A partial thromboplastin
time test is a device used
for primary screening for
coagulation abnormalities,
for evaluation of the effect
of therapy on procoagulant
disorders, and as an assay
for coagulation factor
deficiencies of the intrinsic
coagulation pathwayB.7925 Partial
thromboplastin
time tests2 A partial thromboplastin
time test is a device used for
primary screening for
coagulation abnormalities,
for evaluation of the effect
of therapy on procoagulant
disorders, and as an assay
for coagulation factor
deficiencies of the intrinsic
coagulation pathway.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National17Academy for
Educational
Research and the
advice of
experts.
B.8100 Bothrops atrox
reagent2 A Bothrops atrox reagent
is a device made from
snake venom and used to
determine blood
fibrinogen levels to aid in
the evaluation of
disseminated intravascular
coagulation (nonlocalized
clotting in the blood
vessels) in patients
receiving heparin therapy
(the administration of the
anticoagulant heparin in
the treatment of
thrombosis) or as an aid in
the classification of
dysfibrinogenemia
(presence in the plasma of
functionally defective
fibrinogen).B.8100 Bothrops atrox
reagent2 A Bothrops atrox reagent is
a device made from snake
venom and used to
determine blood fibrinogen
levels to aid in the
evaluation of disseminated
intravascular coagulation
(nonlocalized clotting in the
blood vessels) in patients
receiving heparin therapy
(the administration of the
anticoagulant heparin in the
treatment of thrombosis) or
as an aid in the
classification of
dysfibrinogenemia
(presence in the plasma of
functionally defective
fibrinogen).1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.18B.8150 Calibrator for cell
indices2 A calibrator for cell
indices is a device that
approximates whole blood
or certain blood cells and
that is used to set an
instrument intended to
measure mean cell volume
(MCV), mean corpuscular
hemoglobin (MCH), and
mean corpuscular
hemoglobin concentration
(MCHC), or other cell
indices. It is a suspension
of particles or cells whose
size, shape, concentration,
and other characteristics
have been precisely and
accurately determined.B.8150 Calibrator for cell
indices2 A calibrator for cell indices
is a device that
approximates whole blood
or certain blood cells and
that is used to set an
instrument intended to
measure mean cell volume
(MCV), mean corpuscular
hemoglobin (MCH), and
mean corpuscular
hemoglobin concentration
(MCHC), or other cell
indices. It is a suspension of
particles or cells whose size,
shape, concentration, and
other characteristics have
been precisely and
accurately determined.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.8165 Calibrator for
hemoglobin or
hematocrit
measurement2 A calibrator for
hemoglobin or hematocrit
measurement is a device
that approximates whole
blood, red blood cells, or a
hemoglobin derivative and
that is used to set
instruments intended to
measure hemoglobin, the
hematocrit, or both. It is a
material whose
characteristics have beenB.8165 Calibrator for
hemoglobin or
hematocrit
measurement2 A calibrator for hemoglobin
or hematocrit measurement
is a device that
approximates whole blood,
red blood cells, or a
hemoglobin derivative and
that is used to set
instruments intended to
measure hemoglobin, the
hematocrit, or both. It is a
material whose
characteristics have been1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational19precisely and accurately
determined.precisely and accurately
determined.Research and the
advice of
experts.
B.8625 Hematology
quality control
mixture2 A hematology quality
control mixture is a device
used to ascertain the
accuracy and precision of
manual, semiautomated,
and automated
determinations of cell
parameters such as white
cell count (WBC), red cell
count (RBC), platelet
count (PLT), hemoglobin,
hematocrit (HCT), mean
corpuscular volume
(MCV), mean corpuscular
hemoglobin (MCH), and
mean corpuscular
hemoglobin concentration
(MCHC).B.8625 Hematology
quality control
mixture2 A hematology quality
control mixture is a device
used to ascertain the
accuracy and precision of
manual, semiautomated, and
automated determinations of
cell parameters such as
white cell count (WBC), red
cell count (RBC), platelet
count (PLT), hemoglobin,
hematocrit (HCT), mean
corpuscular volume (MCV),
mean corpuscular
hemoglobin (MCH), and
mean corpuscular
hemoglobin concentration
(MCHC).1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
B.8950 Russell viper
venom reagent1 Russell viper venom
reagent is a device used to
determine the cause of an
increase in the
prothrombin time.B.8950 Russell viper
venom reagent1 Russell viper venom reagent
is a device used to
determine the cause of an
increase in the prothrombin
time.1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the20National
Academy for
Educational
Research and the
advice of
experts.
C.3045 In vitro diagnostic
device for Bacillus
spp. Detection2 An in vitro diagnostic
device for Bacillus species
(spp.) detection is a device
used to detect and
differentiate among
Bacillus spp. and
presumptively identify B.
anthracis and other
Bacillus spp. from cultured
isolates or clinical
specimens as an aid in the
diagnosis of anthrax and
other diseases caused by
Bacillus spp. This device
may consist of Bacillus
spp. antisera conjugated
with a fluorescent dye
(immunofluorescent
reagents) used to
presumptively identify
bacillus-like organisms in
clinical specimens;
bacteriophage used for
differentiating B. anthracis
from other Bacillus spp.1. A new
classification
number.
2. Based on the
U.S. FDA
regulations.21based on susceptibility to
lysis by the phage; or
antigens used to identify
antibodies to B. anthracis
(anti-toxin and anti-
capsular) in serum.
Bacillus infections include
anthrax (cutaneous,
inhalational, or
gastrointestinal) caused by
B. anthracis, and
gastrointestinal disease
and non-gastrointestinal
infections caused by B.
cereus.
C.3373 Nucleic acid-based
in vitro diagnostic
devices for the
detection of
Mycobacterium
tuberculosis
complex (MTB-
complex) and the
genetic mutations
associated with
MTB-complex
antibiotic
resistance in
respiratory
specimens2 Nucleic acid-based in vitro
diagnostic devices for the
detection of
Mycobacterium
tuberculosis complex
(MTB-complex) and the
genetic mutations
associated with MTB-
complex antibiotic
resistance in respiratory
specimens are qualitative
nucleic acid-based devices
that detect the presence of
MTB-complex-associated
nucleic acid sequences in
respiratory samples. TheseC.3373 Nucleic acid-
based in vitro
diagnostic devices
for the detection
of
Mycobacterium
tuberculosis
complex (MTB-
complex) and the
genetic mutations
associated with
MTB-complex
antibiotic
resistance in
respiratory
specimens2 Nucleic acid-based in vitro
diagnostic devices for the
detection of Mycobacterium
tuberculosis complex
(MTB-complex) and the
genetic mutations associated
with MTB-complex
antibiotic resistance in
respiratory specimens are
qualitative nucleic acid-
based devices that detect the
presence of MTB-complex-
associated nucleic acid
sequences in respiratory
samples. These devices are
intended to aid in the1.Amend the
Chinese wording
in the
identification.22devices are intended to aid
in the diagnosis of
pulmonary tuberculosis
and the selection of an
initial treatment regimen
when used in conjunction
with clinical findings and
other laboratory results.
These devices do not
provide confirmation of
antibiotic susceptibility
since other mechanisms of
resistance may exist that
may be associated with a
lack of clinical response to
treatment other than those
detected by the device.diagnosis of pulmonary
tuberculosis and the
selection of an initial
treatment regimen when
used in conjunction with
clinical findings and other
laboratory results. These
devices do not provide
confirmation of antibiotic
susceptibility since other
mechanisms of resistance
may exist that may be
associated with a lack of
clinical response to
treatment other than those
detected by the device.
C.3955 Human
immunodeficiency
virus (HIV) drug
resistance
genotyping assay
using next
generation
sequencing
technology2 The HIV drug resistance
genotyping assay using
next generation
sequencing (NGS)
technology is an in vitro
diagnostic device intended
for use in detecting HIV
genomic mutations that
confer resistance to
specific antiretroviral
drugs. The device is
intended to be used as an
aid in monitoring and
treating HIV infection.1. A new
classification
number.
2. Based on the
U.S. FDA
regulations.23C.4520 Immunofluoromete
r equipment1 Immunofluorometer
equipment for clinical use
with its electrical power
supply is a device used to
measure the fluorescence
of fluorochrome-labeled
antigen-antibody
complexes. The
concentration of these
complexes may be
measured by means of
reflected light. A beam of
light is passed through a
solution in which a
fluorochrome has been
selectively attached to
serum protein antibody
molecules in suspension.
The amount of light
emitted by the
fluorochrome label is
detected by a
photodetector, which
converts light energy into
electrical energy. The
amount of electrical
energy registers on a
readout system such as a
digital voltmeter or a
recording chart. This
electrical readout is calledC.4520 Immunofluoromet
er equipment1 Immunofluorometer
equipment for clinical use
with its electrical power
supply is a device used to
measure the fluorescence of
fluorochrome-labeled
antigen-antibody
complexes. The
concentration of these
complexes may be
measured by means of
reflected light. A beam of
light is passed through a
solution in which a
fluorochrome has been
selectively attached to
serum protein antibody
molecules in suspension.
The amount of light emitted
by the fluorochrome label is
detected by a photodetector,
which converts light energy
into electrical energy. The
amount of electrical energy
registers on a readout
system such as a digital
voltmeter or a recording
chart. This electrical readout
is called the fluorescence
value and is used to measure
the concentration of1.Amend the
Chinese wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.24the fluorescence value and
is used to measure the
concentration of antigen-
antibody complexes.antigen-antibody
complexes.
C.5760 Tryptase test
system2 A tryptase test system is a
device that aids in the
diagnosis of systemic
mastocytosis. It is intended
for in vitro diagnostic use
as an aid in the clinical
diagnosis of patients with
a suspicion of systemic
mastocytosis in
conjunction with other
clinical and laboratory
findings.C.5760 Tryptase test
system2 A tryptase test system is a
device that aids in the
diagnosis of systemic
mastocytosis. It is intended
for in vitro diagnostic use as
an aid in the clinical
diagnosis of patients with a
suspicion of systemic
mastocytosis in conjunction
with other clinical and
laboratory findings.1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for
Educational
Research and the
advice of
experts.
C.5930 Newborn screening
test for severe
combined
immunodeficiency
disorder (SCID)2 A newborn screening test
for SCID is a device
intended to measure T-cell
receptor excision circle
(TREC) DNA obtained
from dried blood spot
specimens on filter paper
using a polymerase chain
reaction based test as an
aid in screening newbornsC.5930 Newborn
screening test2 A newborn screening test
for SCID is a device
intended to measure T-cell
receptor excision circle
(TREC) DNA obtained
from dried blood spot
specimens on filter paper
using a polymerase chain
reaction based test as an aid
in screening newborns for1.Amend the
Chinese name
and the wording
in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the25for SCID. Presumptive
positive results must be
followed up by diagnostic
confirmatory testing. This
test is not intended for use
as a diagnostic test, or for
screening of SCID-like
syndromes, such as
DiGeorge syndrome or
Omenn syndrome. It is
also not intended to screen
for less acute SCID
syndromes, such as leaky
SCID or variant SCID.SCID. Presumptive positive
results must be followed up
by diagnostic confirmatory
testing. This test is not
intended for use as a
diagnostic test, or for
screening of SCID-like
syndromes, such as
DiGeorge syndrome or
Omenn syndrome. It is also
not intended to screen for
less acute SCID syndromes,
such as leaky SCID or
variant SCID.National
Academy for
Educational
Research and the
advice of
experts.
C.5950 Genetic health risk
assessment system2 A genetic health risk
assessment system is a
qualitative in vitro
molecular diagnostic
system used for detecting
variants in genomic
deoxyribonucleic acid
(DNA) isolated from
human specimens that will
provide information to
users about their genetic
risk of developing a
disease. This device does
not determine the person's
overall risk of developing
a disease.C.5950 Genetic health
risk assessment
system2 A genetic health risk
assessment system is a
qualitative in vitro
molecular diagnostic system
used for detecting variants
in genomic
deoxyribonucleic acid
(DNA) isolated from human
specimens that will provide
information to users about
their genetic risk of
developing a disease to
inform lifestyle choices
and/or conversations with a
health care professional.
This device does not
determine the person's1.Amend the
Chinese wording
in the
identification.
2.Revise the text to
conform to the
current situation
of domestic
management.26overall risk of developing a
disease.
D.1100 Arterial blood
sampling kit2 An arterial blood sampling
kit is a device, in kit form,
used to obtain arterial
blood samples from a
patient for blood gas
determinations. The kit
may include a syringe,
needle, cork, and heparin.D.1100 Arterial blood
sampling kit1 An arterial blood sampling
kit is a device, in kit form,
used to obtain arterial blood
samples from a patient for
blood gas determinations.
The kit may include a
syringe, needle, cork, and
heparin.1.Revise the
classification.
2.In view of the
composition of
this product
involving
“J.5570
Hypodermic
single lumen
needle” and
“J.5860 Piston
syringe”, this
classification
number is
changed to Class
2 with a 2-year
grace period.
D.1505 Ventilatory
electrical
impedance
tomograph2 A ventilatory electrical
impedance tomograph is a
non-invasive, non-
radiological ventilatory
device that provides an
assessment of local
impedance variation
within a cross-section of a
patient's thorax.1.A new
classification
number. .
2.Based on the
U.S. FDA
regulations.
G.4780 Intranasal splint 1 An intranasal splint is
intended to minimizeG.4780 Intranasal splint 1 An intranasal splint is
intended to minimize1.Amend the
Chinese name27bleeding and edema and to
prevent adhesions between
the septum and the nasal
cavity. It is placed in the
nasal cavity after surgery
or trauma. The intranasal
splint is constructed from
plastic, silicone, or
absorbent material.bleeding and edema and to
prevent adhesions between
the septum and the nasal
cavity. It is placed in the
nasal cavity after surgery or
trauma. The intranasal splint
is constructed from plastic,
silicone, or absorbent
material.and the wording
in the
identification.
H.1520 Gastrointestinal
Lesion Software
Detection System2 A gastrointestinal lesion
software detection system
is a computer-assisted
detection device used in
conjunction with
endoscopy for the
detection of abnormal
lesions in the
gastrointestinal tract.
This device contains
software to assist in image
detection and may contain
hardware to connect to the
endoscope.1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
situation of the
domestic
industry.
I.4040 Medical apparel 1,2 Surgical apparel are
devices that are intended
to be worn by operating
room personnel during
surgical procedures to
protect both the surgical
patient and the operating
room personnel fromI.4040 Medical apparel 1,2 Surgical apparel are devices
that are intended to be worn
by operating room
personnel during surgical
procedures to protect both
the surgical patient and the
operating room personnel
from transfer of1.Amend the
wording in the
identification.
2.In line with the
Bureau of
Standards and
Inspection of the28transfer of
microorganisms, body
fluids, and particulate
material. Examples
include surgical caps,
hoods, masks, gowns,
operating room shoes and
shoe covers, and isolation
masks and gowns. Surgical
suits and dresses,
commonly known as scrub
suits, are excluded.
Classification: (1) Class 2
devices intended for
surgical procedure
including surgical gowns
and surgical masks. (2)
Class 1 other devices.
Medical masks are
required to meet
performance requirements
from the national standard
CNS 14774(T5017).
For medical masks that are
labelled/claimed to have
the equivalent or above
effect of TN95 or N95, the
sub-micron particulate
filtration efficiency and
exhalation/inhalation
resistance of airflowmicroorganisms, body
fluids, and particulate
material. Examples include
surgical caps, hoods, masks,
gowns, operating room
shoes and shoe covers, and
isolation masks and gowns.
Surgical suits and dresses,
commonly known as scrub
suits, are excluded.
Classification: (1) Class 2
devices intended for
surgical proocedure
including surgical gowns
and surgical masks. (2)
Class 1 other devices.
Medical masks are required
to meet requirements from
the national standard CNS
14774(T5017) or the others
equivalent international
standards. Masks which are
claimed/labelled as N95
should meet D2 class (or
higher) performance
requirements from
disposable dust-proof masks
of the national standard
CNS 14755 (Z2125).
For medical masks that are
labelled/claimed to have theMinistry of
Economic
Affairs to
announced the
revision of CNS
14774 and CNS
14755 standards
on July 15, 2022.
To facilitate the
relevant
industries to
comply with the
standards, a 3-
year grace period
is given.29(replacing “differential
pressure” test) of the mask
should be in accordance
with TN95 class (or
higher) performance
requirements from
disposable dust-proof
masks of the national
standard CNS 14755
(Z2125).equivalent or above effect of
N95, the protection
efficiency and airflow
resistance (pressure
difference during breathing)
of the mask should be in
accordance with D2 class
(or higher) performance
requirements from
disposable dust-proof masks
of the national standard
CNS 14755 (Z2125).
I.4450 Nonabsorbable
gauze for internal
use1 Nonabsorbable gauze for
internal use is a device
made of an open mesh
fabric intended to be used
inside the body or a
surgical incision or applied
to internal organs or
structures, to control
bleeding, absorb fluid, or
protect organs or
structures from abrasion,
drying, or contamination.
The device is woven from
material made of not less
than 50 percent by mass
cotton, cellulose, or a
simple chemical derivative
of cellulose, and contains
x-ray detectable elements.I.4450 Nonabsorbable
gauze for internal
use1 Nonabsorbable gauze for
internal use is a device
made of an open mesh
fabric intended to be used
inside the body or a surgical
incision or applied to
internal organs or structures,
to control bleeding, absorb
fluid, or protect organs or
structures from abrasion,
drying, or contamination.
The device is woven from
material made of not less
than 50 percent by mass
cotton, cellulose, or a simple
chemical derivative of
cellulose, and contains x- ray
detectable elements.1.Amend the
Chinese name
and the wording
in the
identification.
2.To distinguish
thisclassification
number from
“I.4490
Absorbable
hemostatic agent
and dressing”,
the identification
is revised.30I.4454 Non-absorbable,
hemostatic gauze
for temporary
internal use2 A non-absorbable ,
hemostatic gauze for
temporary internal use is a
device intended to be
placed temporarily for
control of severely
bleeding wounds such as
surgical wounds and
traumatic injuries. The
gauze is coated or
impregnated with a
hemostatic material which
may enhance hemostasis
by physical means. The
device is intended to be
removed once the patient
is stabilized.1.A new
classification
number.
2.To distinguish it
from “I.4490
Absorbable
hemostatic agent
and dressing” ,
the A new
classification
number is added.
I.4800 Manual surgical
instrument for
general use1 A manual surgical
instrument for general use
is a nonpowered, hand-
held, or hand-manipulated
device, either reusable or
disposable, intended to be
used in various general
surgical procedures. The
device includes the
applicator, clip applier,
biopsy brush, manual
dermabrasion brush, scrub
brush, cannula, ligature
carrier, chisel, clamp,I.4800 Manual surgical
instrument for
general use1 A manual surgical
instrument for general use is
a nonpowered, hand- held, or
hand-manipulated device,
either reusable or
disposable, intended to be
used in various general
surgical procedures. The
device includes the
applicator, clip applier,
biopsy brush, manual
dermabrasion brush, scrub
brush, cannula, ligature
carrier, chisel, clamp,1.Amend the
Chinese wording
in the
identification.
2.To distinguish it
from "J.5860
Piston syringe",
"J.5570
Hypodermic
single lumen
needle", and
"J.5430
Nonelectrically
powered fluid31contractor, curette, cutter,
dissector, elevator, skin
graft expander, file,
forceps, gouge, instrument
guide, needle guide,
hammer, hemostat,
amputation hook, ligature
passing and knot-tying
instrument, knife, blood
lancet, mallet, disposable
or reusable aspiration and
injection equipment,
disposable or reusable
suturing needle,
osteotome, pliers, rasp,
retainer, retractor, saw,
scalpel blade, scalpel
handle, one-piece scalpel,
snare, spatula, stapler,
disposable or reusable
stripper, stylet, suturing
apparatus for the stomach
and intestine, measuring
tape, and calipers. A
surgical instrument that
has specialized uses in a
specific medical specialty
is classified in separate
regulations in parts D
through P.contractor, curette, cutter,
dissector, elevator, skin
graft expander, file, forceps,
gouge, instrument guide,
needle guide, hammer,
hemostat, amputation hook,
ligature passing and knot-
tying instrument, knife,
blood lancet, mallet,
disposable or reusable
aspiration and injection
needle, disposable or
reusable suturing needle,
osteotome, pliers, rasp,
retainer, retractor, saw,
scalpel blade, scalpel
handle, one-piece scalpel,
snare, spatula, stapler,
disposable or reusable
stripper, stylet, suturing
apparatus for the stomach
and intestine, measuring
tape, and calipers. A
surgical instrument that has
specialized uses in a specific
medical specialty is
classified in separate
regulations in parts D
through P.injector", the
identification is
revised.32J.5150 Nonpowered
flotation therapy
mattress1 A nonpowered flotation
therapy mattress is a
mattress intended for
medical purposes which
contains air, fluid, or
similar materials that have
the functionally equivalent
effect of supporting a
patient and avoiding
excess pressure on local
body areas. The device is
intended to treat or prevent
decubitus ulcers (bed
sores).J.5150 Nonpowered
flotation therapy
mattress1 A nonpowered flotation
therapy mattress is a
mattress intended for
medical purposes which
contains air, fluid, or other
materials that have the
functionally equivalent
effect of supporting a
patient and avoiding excess
pressure on local body
areas. The device is
intended to treat or prevent
decubitus ulcers (bed sores).1.Amend the
Chinese name
and the
wording in the
identification.
J.5780 Medical support
stocking2 A medical support
stocking is a device that is
constructed of elastic
material and designed to
apply controlled pressure
to the leg, providing
pressure that gradually
decreases from the ankle
upwards to prevent the
pooling of blood or
interstitial fluid in the legs
for medical purposes.J.5780 Medical support
stocking1,2 (a)Medical support stocking
to prevent the pooling of
blood in the legs --
(1)Identification: A medical
support stocking to prevent
the pooling of blood in the
legs is a device that is
constructed of elastic
material and designed to
apply controlled pressure to
the leg and that is intended
for use in the prevention of
pooling of blood in the
leg.(2) Classification: Class
2.
(b)Medical support stocking
forgeneral medical1.Amend the
identification
and the
classification.
2.There is no
difference
between non-
medical
devices and
medical
devices within
the scope of the
Class 1
devices.
3.A 2-year grace
period for
medical device33purposes --(1)Identification:
A medical support stocking
for general medical
purposes is a device that is
constructed of elastic
material and designed to
apply controlled pressure to
the leg and that is intended
for medical purposes other
than the prevention of
pooling of blood in the leg.
(2) Classification: Class 1.firms to assess
whether their
licenses should
be changed to
Class 2 or
cancelled.
J.6280 Medical insole 1 A medical insole is a device
intended for medical
purposes that is placed
inside a shoe to relieve the
symptoms of athlete's foot
infection by absorbing
moisture.This product item
is deleted because
of no differences
from non-medical
devices.
J.6785 Manual patient
transfer device1 A manual patient transfer
device is a device
consisting of a wheeled
stretcher and a mechanism
on which a patient can be
placed so that the patient
can be transferred with
minimal disturbance in a
horizontal position to the
stretcher.J.6785 Manual patient
transfer device1 A manual patient transfer
device is a device consisting
of a wheeled stretcher and a
mechanism on which a
patient can be placed so that
the patient can be
transferred with minimal
disturbance in a horizontal
position to the stretcher.1.Amend the
Chinese
wording in the
identification.34M.1100 Retinopathy
detection software
device2 A retinopathy detection
software device is a
software device that
incorporates algorithms to
evaluate ophthalmic
images for diagnostic
screening to identify
retinal diseases or
conditions.1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
situation of the
domestic
industry.
M.4750 Ophthalmic eye
shield1 An ophthalmic eye shield
is a device that consists of
a plastic or aluminum eye
covering intended for
protection during eye
surgery, injury, disease or
retain dressing materials in
place.M.4750 Ophthalmic eye
shield1 An ophthalmic eye shield is
a device that consists of a
plastic or aluminum eye
covering intended to protect
the eye or retain dressing
materials in place.1.Amend the
wording in the
identification to
distinguish it
from non-
medical devices.
M.5844 Corrective
spectacle lens1,2 A corrective spectacle lens
is a glass or plastic device
that is a lens intended to be
worn by a patient in a
spectacle frame to provide
refractive corrections. The
device may be modified to
protect the eyes from
bright sunlight (i.e.,
corrective sunglasses).
Corrective sunglass lenses
may be reflective, tinted,M.5844 Corrective
spectacle lens1 A corrective spectacle lens
is a glass or plastic device
that is a lens intended to be
worn by a patient in a
spectacle frame to provide
refractive corrections. The
device may be modified to
protect the eyes from bright
sunlight (i.e., corrective
sunglasses). Corrective
sunglass lenses may be
reflective, tinted, polarizing,1.Amend the
identification
and the
classification.
2.Because
therapeutic
lenses are for
children
(vulnerable
groups), poor
quality or
improper use35polarizing, or
photosensitized. Products
made with this corrective
spectacle lens include
corrective and protective
sports goggles, such as
swimmers’ goggles, ski
goggles, racquetball eye
guards, and diving
goggles.
Classification: (1) Class1
(2) Class 2 devices are
intended to have the ability
to regulate eyeball growth,
thereby delaying the
progression of myopia or
reducing myopia in
children.or photosensitized. Products
made with this corrective
spectacle lens include
corrective and protective
sports goggles, such as
swimmers’ goggles, ski
goggles, racquetball eye
guards, and diving goggles.will accelerate
the
deterioration of
children's
eyesight and
cause
irreversible
damage. The
identification
and the
classification
are revised.
There is a 2-
year grace
period for the
classification
changes.
O.0007 Wheelchair
positioning devices1 A wheelchair positioning
device is a device intended
for medical purposes that
is used with a wheelchair.
This device is intended as
an aid in supporting and
stabilizing patients with
abnormal muscle tone to
maintain the sitting
posture of the wheelchair.
This device may include:
1) A wheelchair backrest
with aconformal rigid1.A new
classification
number.
2.Based on the
current
situation of the
domestic
industry.36base and a soft cushion. 2)
A wheelchair positioning
stand with an adjustable
mechanical structure that
is locked on the
wheelchair or the backrest.
3) A wheelchair headrest
system with adjustable
support height, fore-aft
position, and angle. 4) An
accessory attached to the
wheelchair utilizes a
contoured seat surface to
provide support for the
pelvis, hip joints, inner and
outer thighs, thus
preventing deformation
due to abnormal muscle
tension.
O.3490 Truncal orthosis 1 A truncal orthosis is a
device intended for
medical purposes to
support or to immobilize
fractures, strains, or
sprains of the neck or
trunk of the body.
Examples of truncal
orthoses are the following:
Abdominal, cervical,
cervical-thoracic, lumbar,
lumbo -sacral, rib fracture,O.3490 Truncal orthosis 1 A truncal orthosis is a
device intended for medical
purposes to support or to
immobilize fractures,
strains, or sprains of the
neck or trunk of the body.
Examples of truncal
orthoses are the following:
Abdominal, cervical,
cervical-thoracic, lumbar,
lumbo-sacral, rib fracture,1.Amend the
Chinese
wording in the
identification.
2.Based on the
Chinese
translation of
medical terms
from the
National
Academy for37sacroiliac, and thoracic
orthoses and clavicle
splints.sacroiliac, and thoracic
orthoses and clavicle splints.Educational
Research.
O.3640 Arm sling/triangle
bandage1 An arm sling/triangle
bandage is a device
intended for medical
purposes to immobilize or
bandage up a part of a
patient's body. This device
is not elastic. It may
include the following
areas: head, chest, arms,
ankles, hands and knees.O.3640 Arm sling 1 An arm sling is a device
intended for medical
purposes to immobilize the
arm, by means of a fabric
band suspended from
around the neck.1.Amend the
Chinese and
English names
and the wording
in the
identification.
2.Based on the
U.S. FDA
regulations,
applicable parts
of the human
body are added.
In addition, to
distinguish it
from the
classification
number "J.5075
Elastic
bandage", it is
specified that the
material of this
product item has
no elasticity..
P.2020 Medical image
communication
device1 A medical image
communications device
provides electronic
transfer of medical image
data between medicalP.2020 Medical image
communication
device1 A medical image
communications device
provides electronic transfer
of medical image data
between medical devices. It1.Amend the
Chinese name
and the wording38devices. It may include a
physical communications
medium, modems, and
interfaces. It may provide
simple image review
software functionality for
medical image processing
and manipulation, such as
grayscale window and
level, zoom and pan, user
delineated geometric
measurements,
compression, or user
added image annotations.
The device does not
perform advanced image
processing or complex
quantitative functions.may include a physical
communications medium,
modems, interfaces, and a
communications protocol.in the
identification.
2.Based on the
U.S. FDA
regulations.
P.2050 Medical image
management and
processing system2 A medical image
management and
processing system is a
device that provides one or
more capabilities relating
to the review and digital
processing of medical
images for the purposes of
interpretation by a trained
practitioner of disease
detection, diagnosis, or
patient management. The
software components mayP.2050 Picture archiving
and
communication
system2 A picture archiving and
communications system is a
device that provides one or
more capabilities relating to
the acceptance, transfer,
display, storage, and digital
processing of medical
images. Its hardware
components may include
workstations, digitizers,
communications devices,
computers, video monitors,
magnetic, optical disk, or1. Amend the
Chinese and
English names
and the
wording in the
identification.
2. Based on the
U.S. FDA
regulations39provide advanced or
complex image processing
functions for image
manipulation,
enhancement, or
quantification that are
intended for use in the
interpretation and analysis
of medical images.
Advanced image
manipulation functions
may include image
segmentation,
multimodality image
registration, or 3D
visualization. Complex
quantitative functions may
include semi-automated
measurements or time-
series measurements.other digital data storage
devices, and hardcopy
devices. The software
components may provide
functions for performing
operations related to image
manipulation, enhancement,
compression or
quantification.
P.2060 Radiological
Computer-assisted
diagnostic software
for lesions
suspicious of
cancer2 A radiological computer-
assisted diagnostic
software for lesions
suspicious of cancer is an
image processing device
intended to aid in the
characterization of lesions
as suspicious for cancer
identified on acquired
medical images such as
magnetic resonance ,1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
situation of the
domestic
industry.40mammography,
radiography, or computed
tomography. The device
characterizes lesions based
on features or information
extracted from the images
and provides information
about the lesion(s) to the
user. Diagnostic and
patient management
decisions are made by the
clinical user.
P.2070 Radiological
Medical image
analyzer2 Medical image analyzers,
including computer-
assisted/aided detection
(CADe) devices for
mammography breast
cancer, ultrasound breast
lesions, and radiograph
lung nodules detection, is
a device that is intended to
identify, mark, highlight,
or in any other manner
direct the clinicians'
attention to portions of a
radiology image that may
reveal abnormalities
during interpretation of
patient radiology images
by the clinicians. This
device incorporates pattern1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
situation of the
domestic
industry.41recognition and data
analysis capabilities and
operates on previously
acquired medical images.
This device is not intended
to replace the review by a
qualified radiologist, and
is not intended to be used
for triage, or to
recommend diagnosis.
P.2080 Radiological
computer aided
triage and
notification
software2 Radiological computer
aided triage and
notification software is an
image processing device
intended to aid in
prioritization and triage of
radiological medical
images. The device
notifies a designated list of
clinicians of the
availability of time
sensitive radiological
medical images for review
based on computer aided
image analysis of those
images performed by the
device. The device does
not mark, highlight, or
direct users' attention to a
specific location in the
original image. The device1.A new
classification
number.
2.Based on the
U.S. FDA
regulations and
the current
situation of the
domestic
industry.42does not remove cases
from a reading queue. The
device operates in parallel
with the standard of care,
which remains the default
option for all cases.Article 7 amended
Article 7
The Regulations shall enter into force on May 1, 2021, excluding classification numbers
“A.3652”, “C.3372”, and “C.3970” from the Annex which shall be effective on July 1, 2022.
The amendments to the Annex to Article 4 shall enter into force on August 22, 2023,
excluding classification numbers “D.1100”, “J.5780”, and “M.5844” from the Annex which
shall be effective on August 22, 2025 and classification number “I.4040” from the Annex
which shall be effective on August 22, 2026.Classification
NumberClassification Name Class Identification
A.0001 Phencyclidine test system 2 Phencyclidine test system is a device to measure the concentration of Phencyclidine (an anesthetic agent) or Phencyclidine an alog
in blood, urine, or/and stomach contents. This device is to monitor the concentration of Phencyclidine or Phencyclidine analog in
diagnosis or diseases treatment in order to ensure the suitability of the treatment.
A.0002 Clinical Chemistry
Electrolyte System1 Clinical chemistry electrolyte system is intended to perform a specific ion test system (e.g., sodium and potassium test systems)
that is used for the qualitative and/or quantitatively measurement of specific ion concentrations in serum, plasma and urine.
A.1020 Acid phosphatase (total or
prostatic) test system2 An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enz yme in
plasma and serum.
A.1025 Adrenocorticotropic
hormone (ACTH) test
system2 An ad renocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and
serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as
Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
A.1030 Alanine amino transferase
(ALT/SGPT) test system1 An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino
transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferas e
measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
A.1035 Albumin test system 2 An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements
are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
A.1040 Aldolase test system 1 An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase
measurements are used in the diagnosis and treatment of the early stages of acute hepatitis an d for certain muscle diseases such as
progressive Duchenne-type muscular dystrophy.
A.1045 Aldosterone test system 2 An aldosterone test system is a device designed for the measurement of aldosterone hormone concentrations in serum and urine.
Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive
secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism,
edematous states, and other conditions of electrolyte imbalance.
A.1050 Alkaline phosphatase or
isoenzymes test system2 An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a g roup
of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used
in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.AnnexA.1055 Newborn screening test
system for amino acids, free
carnitine, and acylcarnitines
using tandem mass
spectrometry.2 A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry is a devic e
that consists of stable isotope internal standards, control materials, extraction solutions, flow solvents, instrumentation, software
packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free
carnitine, and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of amino
acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles that may aid
in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism.
A.1060 Delta-aminolevulinic acid
test system1 A delta -aminolevulinic acid test system is a device intended to measure the level of delta- aminolevulinic acid (a precursor of
porphyrin) in urine. Delta-amin olevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain
porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary exc retion
of various heme compounds including delta-aminolevulinic acid).
A.1065 Ammonia test system 1 An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements
are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
A.1070 Amylase test system 2 An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase
measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
A.1075 Androstenedione test system 1 An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, an d
adrenal glands) in serum. Androstene dione measurements are used in the diagnosis and treatment of females with excessive levels
of androgen (male sex hormone) production.
A.1080 Androsterone test system 1 An androsterone test system is a device intended to measure the hormone androsterone i n serum, plasma, and urine. Androsterone
measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.
A.1085 Angiotensin I and renin test
system2 An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma.
Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.
A.1090 Angiotensin converting
enzyme (A.C.E) test system2 An angiotensin converting enzyme (A.C.E.) test sys tem is a device intended to measure the activity of angiotensin converting
enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as
sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary
disorder affecting the spleen.
A.1095 Ascorbic acid test system 1 An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, se rum, and urine.
Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
A.1100 Asparate amino transferase
(AST/SGOT) test system2 An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate
amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino
transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
A.1110 Bilirubin (total or direct) 2 A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum.test system Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood
cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall
bladder block.
A.1113 Bilirubin (total and
unbound) in the neonate test
system1 A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound)
in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
A.1115 Urinary bilirubin and its
conjugates (nonquantitative)
test system1 A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates
in urin e. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain
liver diseases.
A.1117 B-type natriuretic peptide
test system2 The B-type natriuretic peptide (BNP) test system is an in vitro di agnostic device intended to measure BNP in whole blood and
plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.
A.1118 Biotinidase test system 2 The biotinidase test system is an in vitro diagnostic de vice intended to measure the activity of the enzyme biotinidase in blood.
Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in
infants, characterized by the inability to utilize die tary protein bound vitamin or to recycle endogenous biotin. The deficiency may
result in irreversible neurological impairment.
A.1120 Blood gases (PCO 2, PO 2)
and blood pH test system2 A blood gases (PCO 2, PO 2) and blood pH test system is a device intende d to measure certain gases in blood, serum, plasma or pH
of blood, serum, and plasma. Measurements of blood gases ( PCO 2, PO 2) and blood pH are used in the diagnosis and treatment of
life-threatening acid-base disturbances.
A.1130 Blood volume test system 1 A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used
in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute incre ase in
erythrocyte mass and total blood volume).
A.1135 C-peptides of proinsulin test
system1 A C-peptides of proinsulin test system is a device intended to measure C- peptides of proinsulin levels in serum, plasma, and urine.
Measurements of C-peptides o f proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion,
including diabetes mellitus.
A.1140 Calcitonin test system 2 A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyroca lcitonin) levels in plasma and
serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glan ds,
including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
A.1145 Calcium test system 2 A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the
diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and teta ny (intermittent muscular
contractions or spasms).
A.1150 Calibrator 2 A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are use d in thedetermination of values in the measurement of substances in human specimens.
A.1155 Human chorionic
gonadotropin (HCG) test
system2,3 (a)Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy-- (1)Identification: A human
chorionic gonadotropin (HCG) test system is a dev ice intended for the early detection of pregnancy is intended to measure
HCG, a placental hormone, in plasma or urine. (2)Classification: Class 2.
(b)Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy --
(1)Identification: A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early
detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain
tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)Classification: Class 3.
A.1160 Bicarbonate/carbon dioxide
test system2 A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in pl asma, serum, and whole
blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disord ers
associated with changes in body acid-base balance.
A.1163 Cardiac allograft gene
expression profiling test
system2 A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) expression lev el of
multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid in the identification of a
low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.
A.1165 Catecholamines (total) test
system1 A catecholamines (total) test system is a device intended to determine whe ther a group of similar compounds (epinephrine,
norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and
treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreti ng tumors (pheochromocytoma,
neuroblastoma, ganglioneuroma, and retinoblastoma).
A.1170 Chloride test system 2 A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride
measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic
acidosis.
A.1175 Cholesterol (total) test
system1 A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum . Cholesterol measurements are
used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metaboli sm
disorders.
A.1177 Cholylglycine test system 2 A cholylglycine test system is a device intended t o measure the bile acid cholylglycine in serum. Measurements obtained by this
device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.
A.1180 Chymotrypsin test system 1 A chymotrypsin test system i s a device intended to measure the activity of the enzyme chymotrypsin in blood and other body fluids
and in feces. Chymotrypsin measurements are used in the diagnosis and treatment of pancreatic exocrine insufficiency.
A.1185 Compound S (11-
deoxycortisol) test system1 A compound S (11-dioxycortisol) test system is a device intended to measure the level of compound S (11- dioxycortisol) in plasma.
Compound S is a steroid intermediate in the biosynthesis of the adrenal hormone cortisol. Measurements of comp ound S are used
in the diagnosis and treatment of certain adrenal and pituitary gland disorders resulting in clinical symptoms of masculiniza tionand hypertension.
A.1187 Conjugated sulfolithocholic
acid (SLCG) test system2 A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG in serum. Measurements
obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.
A.1190 Copper test system 1 A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of copper are us ed
in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a hereditary disease primarily of the
liver and nervous system). Test results are also used in monitoring patients with Hodgkin's disease (a disease primarily of t he
lymph system).
A.1195 Corticoids test system 1 A corticoids test system is a device intended to measure the levels of corti coids (hormones of the adrenal cortex) in serum and
plasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands,
especially those associated with hypertension and electrolyte disturbances.
A.1200 Corticosterone test system 1 A corticosterone test system is a device intended to measure corticosterone (a steroid secreted by the adrenal gland) levels in
plasma. Measurements of corticosterone are used in the diagnosis and treatment of adrenal diso rders such as adrenal cortex
disorders and blocks in cortisol synthesis.
A.1205 Cortisol (hydrocortisone and
hydroxycorticosterone) test
system2 A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortiso l hormones secreted
by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of th e
adrenal gland.
A.1210 Creatine test system 1 A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in
biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle di seases
and endocrine disorders including hyperthyroidism.
A.1215 Creatine phosphokinase/
creatine kinase or
isoenzymes test system2 A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme
creatine phosphokinase or its isoenzymes (a group of enzymes w ith similar biological activity) in plasma and serum. Measurements
of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle dise ases
such as progressive, Duchenne-type muscular dystrophy.
A.1220 Acute Kidney Injury Test
System2 An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the
assessment of a patient's risk for developing acute kidney injury. Test results are inte nded to be used in conjunction with other
clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.
A.1225 Creatinine test system 2 A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used
in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring othe r urine
analytes.
A.1230 Cyclic AMP test system 2 A cyclic AMP test system is a device intended to measure the level of adenosine 3', 5'- monophosphate (cyclic AMP) in plasma,
urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, includi nghyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and
treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated leve ls of
serum calcium.)
A.1235 Cyclosporine test system 2 A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the
management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and
chromatographic assays for cyclosporine.
A.1240 Cystine test system 1 A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the
diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).
A.1245 Dehydroepiandrosterone
(free and sulfate) test system1 A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehy droepiandrosterone (DHEA) and its
sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatm ent
of DHEA-secreting adrenal carcinomas.
A.1250 Desoxycorticosterone test
system1 A desoxycort icosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC
measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism (excess retention of sodium a nd
loss of potassium) and other disorders of the adrenal gland.
A.1255 2,3-Diphosphoglyceric acid
test system1 A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3- DPG) in erythrocytes
(red blood cells). Measurements of 2,3-di phosphoglyceric acid are used in the diagnosis and treatment of blood disorders that
affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.
A.1260 Estradiol test system 1 An estradiol test system is a devic e intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are
used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated
pregnancy.
A.1265 Estriol test system 1 An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnan t females.
Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
A.1270 Estrogens (total, in
pregnancy) test system1 As estrogens (total, in pregnancy) test system is a device intended to measure total estrogens in plasma, serum, and urine du ring
pregnancy. The device primarily measures estrone plus estradi ol. Measurements of total estrogens are used to aid in the diagnosis
and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
A.1275 Estrogens (total,
nonpregnancy) test system1 As estrogens (total, nonpregnancy) test system is a device intended to measure the level of estrogens (total estrone, estradiol, and
estriol) in plasma, serum, and urine of males and nonpregnant females. Measurement of estrogens (total, nonpregnancy) is used in
the diagnosis and treatment of numerous disord ers, including infertility, amenorrhea (absence of menses) differentiation of primary
and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
A.1280 Estrone test system 1 An estrone test syst em is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used
in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secon daryovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
A.1285 Etiocholanolone test system 1 An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metab olic
product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and
treatment of disorders of the testes and ovaries.
A.1290 Fatty acids test system 1 A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in
the diagnosis and treatment of various disorders of lipid metabolism.
A.1295 Folic acid test system 2 A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are
used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnor mal
red blood cell series) in the bone marrow.
A.1300 Follicle-stimulating
hormone test system1 A follicle-stimulating hormone test system is a device intended to measure follicle- stimulating hormone (FSH) in plasma, serum,
and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
A.1305 Formiminoglutamic acid
(FIGLU) test system1 A formiminoglutamic acid (FIGLU) test system is a device intended to measure formiminolutamic acid in urine. FIGLU
measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic
anemia.
A.1310 Galactose test system 1 A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the
diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.
A.1315 Galactose-1-phosphate
uridyl transferase test
system2 A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-
phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1- phosphate uridyl transferase are used
in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
A.1320 Gastric acidity test system 1 A gastric acidity test system is a device intended to measure the acidity of gastric fluid. Measurements of gastric acidity a re used
in the diagnosis and treatment of patients with peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin- secreting tumor
of the pancreas), and related gastric disorders.
A.1325 Gastrin test system 1 A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are us ed
in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger- Ellison syndrome (peptic ulcer due to
a gastrin-secreting tumor of the pancreas).
A.1330 Globulin test system 1 A globulin test system is a device intended to measure glo bulins (proteins) in plasma and serum. Measurements of globulin are
used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple my eloma,
and other disorders of blood globulins.
A.1335 Glucagon test system 1 A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon
measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, includin gdiabetes mellitus, hypoglycemia, and hyperglycemia.
A.1340 Urinary glucose
(nonquantitative) test
system2 A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucos e
(nonquantitative) m easurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes
mellitus, hypoglycemia, and hyperglycemia.
A.1345 Glucose test system 2 A glucose test system is a device intended to measure glucose quantitativel y in blood and other body fluids. Glucose measurements
are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia,
and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
A.1350 Continuous Glucose
Monitor Secondary Display2 A continuous glucose monitor secondary display is identified as a device intended to be used for passive real- time monitoring of
continuous glucose monitoring data. It must not be capable of serving as a stand- alone primary display device. The primary display
device, which is not a part of the continuous glucose monitor secondary display, directly receives the glucose data (for exam ple,
it communicates directly with transmitter) from the continuous glucose meter, which is not a part of the continuous glucose monitor
secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a low or
high glucose value. A continuous glucose monitor secondary display can be used by caregivers of people with diabetes to monitor
a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary display if the data fro m
the primary display device is modified (for example, predicting fut ure glucose values) or the patient can use the secondary display
in lieu of a primary display device (for example, the primary display device is blinded or the primary display does not have to be
near the person wearing the sensor and transmitter).
A.1355 Integrated continuous
glucose monitoring system2,3 An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids
continuously or frequently for a specified period of time.
Classification: (1) Class 2 devices are intended to be used alone for diabetes self- management. (2) Class 3 devices are intended to
transmit glucose measurement data to automated insulin dosing systems, and to adjust insulin dose.
A.1358 Insulin therapy adjustment
device2 An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data
from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens
for patients with diabetes mellitus. The device must not be intended for use in implementing automated insulin dosing.
A.1360 Gamma-glutamyl
transpeptidase and
isoenzymes test system1 A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-
glutamyl transpeptidase (GGTP) in plasma and serum. Gamma- glutamyl transpeptidase and isoenzymes measurements are used
in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
A.1365 Glutathione test system 1 A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid ) in
erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug- induced hemolytic
(erythrocyte destroying) anemias due to an inherited enzyme deficiency.
A.1370 Human growth hormone test 1 A human growth hormone test system is a device intended to measure the level s of human growth hormone in plasma. Humansystem growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary
gland.
A.1373 Hemoglobin A1c test system 2 A hemoglobin A1c test system is a device us ed to measure the percentage concentration of hemoglobin A1c in blood. Measurement
of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for
developing diabetes mellitus.
A.1375 Histidine test system 1 A histidine test system is a device intended to measure free histidine (an amino acid) in plasma and urine. Histidine measure ments
are used in the diagnosis and treatment of hereditary histidinemia characterized by excess histidine i n the blood and urine often
resulting in mental retardation and disordered speech development.
A.1377 Urinary homocystine
(nonquantitative) test
system2 A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid
cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosy stine
in urine), a heritable metabolic disorder which may cause mental retardation.
A.1380 Hydroxybutyric
dehydrogenase test system1 A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybuty ric
dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of my ocardial infarction,
renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic
anemias) and, to a lesser degree, liver disease.
A.1385 17-Hydroxycorticosteroids
(17-ketogenic steroids) test
system1 A 17-hydroxycorticosteroids (17- ketogenic steroids) test system is a device intended to measure corticosteroids that possess a
dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortis ol,
cortisone 11- desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the
adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of
various diseases of the adrenal or pituitary glands and gonadal disorders.
A.1390 5-Hydroxyindole acetic
acid/serotonin test system1 A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in
urine.
Measurements of 5- hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine
tissue.
A.1395 17-Hydroxyprogesterone
test system1 A 17-hydroxyprogesterone test system is a device intended to measure 17- hydroxyprogesterone (a steroid) in plasma and serum.
Measurements of 17- hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the
ovaries.
A.1400 Hydroxyproline test system 1 A hydroxyproline tes t system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline
measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as P aget's
disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.
A.1405 Immunoreactive insulin test 1 An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma.system Immunoreactive insulin measurements are use d in the diagnosis and treatment of various carbohydrate metabolism disorders,
including diabetes mellitus, and hypoglycemia.
A.1410 Iron (non-heme) test system 1 An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non- heme)
measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease
associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofusci n, and characterized
by pigmentation of the skin), and chronic renal disease.
A.1415 Iron-binding capacity test
system1 An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron- binding capacity
measurements are used in the diagnosis and treatment of anemia.
A.1420 Isocitric dehydrogenase test
system1 An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme isocitric dehydrogenase in serum
and plasma. Isocitric dehy drogenase measurements are used in the diagnosis and treatment of liver disease such as viral hepatitis,
cirrhosis, or acute inflammation of the biliary tract; pulmonary disease such as pulmonary infarction (local arrest or sudden
insufficiency of the blood supply to the lungs), and diseases associated with pregnancy.
A.1430 17-Ketosteroids test system 1 A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17- ketosteroids are used
in the diagnosis and trea tment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including
hypertension, diabetes, and hypothyroidism.
A.1435 Ketones (nonquantitative)
test system1 A ketones (nonquantitative) test system is a device intended to iden tify ketones in urine and other body fluids. Identification of
ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body flui ds) or
ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on
ketogenic diets and patients with diabetes.
A.1440 Lactate dehydrogenase test
system1 A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate de hydrogenase in serum.
Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis,
cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
A.1445 Lactate dehydrogenase
isoenzymes test system2 A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzym es
(a group of enzymes with similar biological activi ty) in serum. Measurements of lactate dehydrogenase isoenzymes are used in
the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.
A.1450 Lactic acid test system 1 A lactic acid test system is a device intended t o measure lactic acid in whole blood and plasma. Lactic acid measurements that
evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
A.1455 Lecithin/sphingomyelin
ratio in amniotic fluid test
system2 A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in
amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosp horus). Measurements
of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.
A.1460 Leucine aminopeptidase test 1 A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino- peptidase in serum,system plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as vira l
hepatitis and obstructive jaundice.
A.1465 Lipase test system 1 A lipase test system is a devic e intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in
diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
A.1470 Lipid (total) test system 1 A lipid (total) test system is a device intended to measure total lipids (fats or fat- like substances) in serum and plasma. Lipid (total)
measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.
A.1475 Lipoprotein test system 1 A lipoprotein test system is a chemical analysis device intended to measure lipoprotein in serum and plasma. Lipoprotein
measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various
liver and renal diseases.
A.1485 Luteinizing hormone test
system1 A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone
measurements are used in the diagnosis and treatment of gonadal dysfunction.
A.1490 Lysozyme (muramidase)
test system1 A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme
(muramidase) in serum, plasma, leukocytes, and ur ine. Lysozyme measurements are used in the diagnosis and treatment of
monocytic leukemia and kidney disease.
A.1495 Magnesium test system 1 A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurement s are
used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia
(abnormally high plasma levels of magnesium).
A.1500 Malic dehydrogenase test
system1 A malic dehydrogenase test system is a devic e that is intended to measure the activity of the enzyme malic dehydrogenase in serum
and plasma. Malic dehydrogenase measurements are used in the diagnosis and treatment of muscle and liver diseases, myocardial
infarctions, cancer, and blood disorders such as myelogenous (produced in the bone marrow) leukemia.
A.1505 Mucopolysaccharides
(nonquantitative) test
system1 A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urin e.
Mucopolysac charide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect
bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.
A.1509 Methylmalonic acid
(nonquantitative) test
system2 A methylmalonic acid (nonquantitative) test system is a device intended to identify methylmalonic acid in urine. The identifi cation
of methylmalonic acid in urine is used in the diagnosis and treatment of methylmalonic aciduria, a heritable metabolic disorder
which, if untreated, may cause mental retardation.
A.1510 Nitrite (nonquantitative) test
system1 A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification i s used in the diagnosis
and treatment of urinary tract infection of bacterial origin.
A.1515 Nitrogen (amino-nitrogen)
test system1 A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and u rine.
Nitrogen (amino- nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renaldisorders.
A.1520 5'-Nucleotidase test system 1 A 5'-nucleotidase test system is a device intended to measure the activity of the enzyme 5'- nucleotidase in serum and plasma.
Measurements of 5'- nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver
and bone diseases in the presence of elevated serum alkaline phosphatase activity.
A.1530 Plasma oncometry test
system1 A plasma oncometry test system is a device intended to measure plasma oncotic pressure. Plasma oncotic pressure is that porti on
of the total fluid pressure contributed by proteins and other molecules too large to pass through a specified membrane.
Measurements of plasma oncotic pressure are used in the diagnosis and treatment of dehydration and circulatory disorders rela ted
to low serum protein levels and increased capillary permeability, such as edema and shock.
A.1535 Ornithine carbamyl
transferase test system1 An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine carbamyl
transferase (OCT) in serum. Ornithine carbamyl transferase measurement s are used in the diagnosis and treatment of liver diseases,
such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), cirrhosis, and liver metastases.
A.1540 Osmolality test system 1 An osmolality test system is a device inten ded to measure ionic and nonionic solute concentration in body fluids, such as serum
and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney
diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.
A.1542 Oxalate test system 1 An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are use d to
aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.
A.1545 Parathyroid hormone test
system2 A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma.
Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of
calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium
metabolism.
A.1550 Urinary pH
(nonquantitative) test
system1 A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to ev aluate
the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with
certain diets.
A.1555 Phenylalanine test system 2 A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine.
Measurements of phenyl alanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may
cause mental retardation.
A.1560 Urinary phenylketones
(nonquantitative) test
system1 A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid)
in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria wh ich,
if untreated, may cause mental retardation.
A.1565 6-Phosphogluconate
dehydrogenase test system1 A 6-phosphogluconate dehydrogenase test system is a device intended to measure the activity of the enzyme 6- phosphogluconate
dehydrogenase (6 PGD) in serum and erythrocytes. Measurements of 6-phosphogluconate dehydroge nase are used in the diagnosisand treatment of certain liver diseases (such as hepatitis) and anemias.
A.1570 Phosphohexose isomerase
test system1 A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme phosphohe xose isomerase in
serum. Measurements of phosphohexose isomerase are used in the diagnosis and treatment of muscle diseases such as muscular
dystrophy, liver diseases such as hepatitis or cirrhosis, and metastatic carcinoma.
A.1575 Phospholipid test system 1 A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids
are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.
A.1580 Phosphorus (inorganic) test
system1 A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine.
Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gl and
and kidney diseases, and vitamin D imbalance.
A.1585 Human placental lactogen
test system2 A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also know n
as human chorionic somatomammotrophin (H CS)), in maternal serum and maternal plasma. Measurements of human placental
lactogen are used in the diagnosis and clinical management of high- risk pregnancies involving fetal distress associated with
placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-
maturity, placental insufficiency, or possible miscarriage.
A.1590 Porphobilinogen test system 1 A porphobilinogen test system is a device intended to measure porphobilinogen (one o f the derivatives of hemoglobin which can
make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyr ias
(primarily inherited diseases associated with disturbed porphyrine metabolism), lead poisoning, and other diseases characterized
by alterations in the heme pathway.
A.1595 Porphyrins test system 1 A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a
constituent of hemoglo bin, and related compounds) in urine and feces. Measurements obtained by this device are used in the
diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin
metabolism), and other diseases characterized by alterations in the heme pathway.
A.1600 Potassium test system 2 A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this
device are used to monitor electrolyte balance in th e diagnosis and treatment of diseases conditions characterized by low or high
blood potassium levels.
A.1605 Pregnanediol test system 1 A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progester one) in
urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
A.1610 Pregnanetriol test system 1 A pregnanetriol test system is a device intended to measure pregnanetriol (a precursor in the biosynthesis of the adrenal hormone
cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment of congenital adrenal hyperp lasia
(congenital enlargement of the adrenal gland).
A.1615 Pregnenolone test system 1 A pregnenolone test system is a device intended to measure pregnenolone (a precursor in the biosynthesis of the adrenal hormo necortisol and adrenal androgen) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment
of diseases of the adrenal cortex or the gonads.
A.1620 Progesterone test system 1 A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements
obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
A.1625 Prolactin (lactogen) test
system1 A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in se rum
and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary
gland or of the hypothalamus portion of the brain.
A.1630 Protein (fractionation) test
system1 A protein (fractionation) test system is a device intend ed to measure protein fractions in blood, urine, cerebrospinal fluid, and other
body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants o f
proteins produced in diseases with tissue destruction.
A.1635 Total protein test system 1 A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by thi s
device are used in the diagnosis and treatment of a variety of diseases involving the l iver, kidney, or bone marrow as well as other
metabolic or nutritional disorders.
A.1640 Protein-bound iodine test
system1 A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein- bound
iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.
A.1645 Urinary protein or albumin
(nonquantitative) test
system1 A urinary protein or albumin (nonquantitative) test system is a device intended to identify protein s or albumin in urine.
Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions s uch as
renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
A.1650 Pyruvate kinase test system 1 A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood
cells). Measurements obtained by this device are used in the diagnosis and treatment o f various inherited anemias due to pyruvate
kinase deficiency or of acute leukemias.
A.1655 Pyruvic acid test system 1 A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of
carbohydrate) in plasma.
Measurements obtained by this device are used in the evaluation of electrolyte metabolism, and in the diagnosis and treatment of
acid-base and electrolyte disturbances or anoxia (the reduction of oxygen in body tissues).
A.1660 Quality control material
(assayed and unassayed)1,2 (a) Identification: A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medica l
purposes for use in a test system to estimate test precision and to detect systematic analytica l deviations that may arise from reagent
or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in
interlaboratory surveys. This generic type of device includes controls (assayed and unass ayed) for blood gases, electrolytes,
enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
(b) Classification: (1) Class 1: The device is not made from serum of human or animal origin, or is used for proficiency testing ininterlaboratory surveys. (2) Class 2: The device is made from serum of human or animal origin, or is used for drug abuse detection.
A.1665 Sodium test system 2 A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Mea surements obtained by this device
are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus
(chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hyp ertension, Addison's disease
(caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases
involving electrolyte imbalance.
A.1670 Sorbitol dehydrogenase test
system1 A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum.
Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis.
A.1675 Blood specimen collection
device2 A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to
separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection
tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes , blood sampling paper and other similar
devices.
A.1678 Tacrolimus test system 2 A tacrolimus test system is a device intended to quantitative ly determine tacrolimus concentrations as an aid in the management
of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographi c
assays for tacrolimus.
A.1680 Testosterone test system 1 A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine.
Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens),
including primary and secondary hypogonadism, delayed or precocious puberty, impotence in male’s and, in female’ s hirsutism
(excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
A.1685 Thyroxine-binding globulin
test system2 A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)- binding globulin (TBG), a plasma
protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diag nosis and treatment
of thyroid diseases.
A.1690 Thyroid stimulating
hormone test system2 A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as
thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the
anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
A.1695 Free thyroxine test system 2 A free thyroxine test system is a device intended to measure free ( not protein bound) thyroxine (thyroid hormone) in serum or
plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may
therefore determine the clinical metabolic status of thyroxine. Meas urements obtained by this device are used in the diagnosis and
treatment of thyroid diseases.
A.1700 Total thyroxine test system 2 A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum
and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.A.1705 Triglyceride test system 1 A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma . Measurements obtained
by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, othe r diseases
involving lipid metabolism, or various endocrine disorders.
A.1710 Total triiodothyronine test
system1 A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma.
Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
A.1715 Triiodothyronine uptake test
system1 A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid
hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-bin ding prealbumin, and albumin of serum and
plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronin e
uptake are used in the diagnosis and treatment of thyroid disorders.
A.1720 Triose phosphate isomerase
test system1 A triose phosphate isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomeras e in
erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis (the energy- yielding conversion
of glucose to lactic acid in various tissues). Measurements obtained by this device are used in the diagnosis and treatment o f
congenital triose phosphate isomerase enzyme deficiency, which causes a type of hemolytic anemia.
A.1725 Trypsin test system 1 A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the
breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by t his device are used in the diagnosis
and treatment of pancreatic disease.
A.1730 Free tyrosine test system 1 A free tyrosine test system is a device intended to measure free tyrosine (an ami no acid) in serum and urine. Measurements obtained
by this device are used in the diagnosis and treatment of diseases such as congenital tyrosinemia (a disease that can cause
liver/kidney disorders) and as an adjunct to the measurement of phenylalanine in detecting congenital phenylketonuria (a dise ase
that can cause brain damage).
A.1770 Urea nitrogen test system 2 A urea nitrogen test system is a device intended to measure urea nitrogen (an end- product of nitrogen metabolism) in whole blood,
serum, plasma, and urine. Measurements obtained by this device are used in th e diagnosis and treatment of certain renal and
metabolic diseases.
A.1775 Uric acid test system 1 A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device
are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia,
psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
A.1780 Urinary calculi (stones) test
system1 A urinary calcul i (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in
the diagnosis and treatment of calculi of the urinary tract.
A.1785 Urinary urobilinogen
(nonquantitative) test
system1 A urinary urob ilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment
degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treat ment
of liver diseases and hemolytic (red cells) disorders.A.1790 Uroporphyrin test system 1 A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are us ed
in the diagnosis and treatment of porphyrias (primar ily inherited diseases associated with disturbed porphyrin metabolism), lead
poisoning, and other diseases characterized by alterations in the heme pathway.
A.1795 Vanilmandelic acid test
system1 A vanilmandelic acid test system is a device intended to m easure vanilmandelic acid in urine. Measurements of vanilmandelic acid
obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive
conditions.
A.1805 Vitamin A test system 1 A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are
used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestina l
disorders.
A.1810 Vitamin B12 test system 2 A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by
this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
A.1815 Vitamin E test system 1 A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device
are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.
A.1820 Xylose test system 1 A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by t his
device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in w hich there is
subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).
A.1825 Vitamin D test system 2 A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25- hydroxyvitamin
D (25-OH- D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D
sufficiency.
A.1840 Total 25-hydroxyvitamin D
mass spectrometry test
system2 A total 25-hydrox yvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative
determination of total 25-hydroxyvitamin D (25-OH-D) in serum or plasma to be used in the assessment of vitamin D sufficiency.
A.2140 Centrifugal chemistry
analyzer for clinical use1 A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and
spectrophotometrically measure concentrations of the sample constituents. This de vice is intended for use in conjunction with
certain materials to measure a variety of analytes.
A.2150 Continuous flow sequential
multiple chemistry analyzer
for clinical use1 A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to
simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is
intended for use in conjunction with certain materials to measure a variety of analytes.
A.2160 Discrete photometric
chemistry analyzer for
clinical use1 A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by
performing automatically various steps such as pipetting, pre paring filtrates, heating, and measuring color intensity. This device is
intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incor poratevarious instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-
wavelength photometers. Some models of the device may include reagent- containing components that may also serve as reaction
units.
A.2170 Micro chemistry analyzer
for clinical use1 A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing
automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishin g
characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is inten ded
for use in conjunction with certain materials to measure a variety of analytes. This item does not include instrumentation for
clinical multiplex test systems (A.2570) to measure and analyze multiple signals generated from a single test.
A.2250 Gas liquid chromatography
system for clinical use1 A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a
mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The devic e
may include accessories such as columns, gases, column supports, and liquid coating.
A.2260 High pressure liquid
chromatography system for
clinical use1 A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds
from a solution by processing the mixture of compounds (solutes) t hrough a column packed with materials of uniform size
(stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by
absorption, sieving, partition, or selective affinity.
A.2265 High throughput genomic
sequence analyzer for
clinical use2 A high throughput genomic sequence analyzer for clinical use is an analytical instrument system intended to generate, measure
and sort signals in order to analyze nucleic acid sequences in a clinical sample. Th e device may include a signal reader unit; reagent
handling, dedicated instrument control, and other hardware components; raw data storage mechanisms; data acquisition software ;
and software to process detected signals.
A.2270 Thin-layer chromatography
system for clinical use1 A thin- layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from
a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material ( e.g., cellulose, alumina,
etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
A.2300 Colorimeter, photometer, or
spectrophotometer for
clinical use1 A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted,
transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a
specific wavelength.
A.2320 Beta or gamma counter for
clinical use1 A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical
samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements ar e useful in the
diagnosis and treatment of various disorders.
A.2400 Densitometer/scanner
(integrating, reflectance,
TLC, or1 A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromat ogram) for clinical use is device
intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell
measurement of the light transmission through a given area of the medium or, in the case of the rad iochromatogram scanner, byradiochromatogram) for
clinical usemeasurement of the distribution of a specific radio-active element on a radiochromatogram.
A.2485 Electrophoresis apparatus
for clinical use1 An electrophoresis apparatus for clinical use is a device intended to separate molecu les or particles, including plasma proteins,
lipoproteins, enzymes, and hemoglobulin on the basis of their net charge in specified buffered media. This device is used in
conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.
A.2500 Enzyme analyzer for clinical
use1 An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic
measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of
enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.
A.2540 Flame emission photometer
for clinical use1 A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and
other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of c ertain
disorders (e.g., electrolyte imbalance and heavy metal intoxication), therefore, it is useful in diagnosis and treatment of those
disorders.
A.2560 Fluorometer for clinical use 1 A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of
certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain
materials to measure a variety of analytes.
A.2570 Instrumentation for clinical
multiplex test systems.2 Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay
from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that est ablish a
single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device in cludes
a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control , and other
hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.
A.2700 Nephelometer for clinical
use1 A nephelometer for clinical use is a device intended to estimate the conce ntration of particles in a suspension by measuring their
light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjuncti on with
certain materials to measure the concentration of a variety of analytes.
A.2720 Plasma oncometer for
clinical use1 A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the tot al
plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable
membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are
useful in the diagnosis and treatment of these disorders.
A.2730 Osmometer for clinical use 1 An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pr essure
required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solu te concentration
when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressur e,
freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as t he measurementof the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.
A.2800 Refractometer for clinical
use1 A refractometer for clinical use is a device intended to determine the amou nt of solute in a solution by measuring the index of
refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to
measure the concentration of certain analytes (solutes), such a pl asma total proteins and urinary total solids. Measurements
obtained by this device are used in the diagnosis and treatment of certain conditions.
A.2850 Atomic absorption
spectrophotometer for
clinical use1 An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and metals (e.g.,
lead and mercury) in human specimens. The metal elements are identified according to the wavelength and intensity of the ligh t
that is absorbed when the specimen is converted to the atomic vapor phase. Measurements obtained by this device are used in the
diagnosis and treatment of certain conditions.
A.2860 Mass spectrometer for
clinical use1 A mass spectrometer for clinical use is a device intended to identify inorganic or o rganic compounds (e.g., lead, mercury, and
drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an
electrical and magnetic field according to their mass.
A.2900 Automated urinalysis
system1 An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents o f
urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measur e
a variety of urinary analytes.
A.2920 Plasma viscometer for
clinical use1 A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period
required for the plasma to flow a measured distance th rough a calibrated glass tube. Measurements obtained by this device are
used to monitor changes in the amount of solids present in plasma in various disorders.
A.3030 Acetaminophen tests system 2 An acetaminophen test system is a device intended to measur e acetaminophen, an analgesic and fever reducing drug, in serum.
Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
A.3035 Amikacin test system 2 An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma.
Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of
amikacin to ensure appropriate therapy.
A.3040 Alcohol test system 2 An alcohol test system is a device intend ed to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids
(e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of al cohol
intoxication and poisoning.
A.3050 Breath-alcohol test system 1 A breath-alcohol test system is a device intended to measure alcohol in the human breath. Measurements obtained by this device
are used in the diagnosis of alcohol intoxication.
A.3080 Breath nitric oxide test
system2 A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of cha nges
in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti- inflammatory
therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combin eschemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.
A.3100 Amphetamine test system 2 An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma
and urine. Measurements obtained by this device are used in the diagnosis and treatmen t of amphetamine use or overdose and in
monitoring levels of amphetamine to ensure appropriate therapy.
A.3110 Antimony test system 1 An antimony test system is a device intended to measure antimony, a heavy metal, in urine, blood, vomitus, and stomach co ntents.
Measurements obtained by this device are used in the diagnosis and treatment of antimony poisoning.
A.3120 Arsenic test system 1 An arsenic test system is a device intended to measure arsenic, a poisonous heavy metal, in urine, vomitus, stomach co ntents,
nails, hair, and blood. Measurements obtained by this device are used in the diagnosis and treatment of arsenic poisoning.
A.3150 Barbiturate test system 2 A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and
gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and
in monitoring levels of barbiturate to ensure appropriate therapy.
A.3170 Benzodiazepine test system 2 A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs ,
in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlor zepate,
flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine us e
or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.
A.3200 Clinical toxicology
calibrator2 A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of re ference
that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicol ogy calibrator
can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.).
A.3220 Carbon monoxide test
system1 A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound
to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or
confirmation of carbon monoxide poisoning.
A.3240 Cholinesterase test system 1 A cholinesterase test syste m is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of
acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholines terase
is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in
plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treat ment
of cholinesterase inhibition disorders (e.g., insecticide poisoning, and succinylcholine poisoning).
A.3250 Cocaine and cocaine
metabolite test system2 A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine)
in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or
overdose.
A.3270 Codeine test system 2 A codeine test system is a device intended to measure codeine (a narcotic pain-relieving dr ug) in serum and urine. Measurements
obtained by this device are used in the diagnosis and treatment of codeine use or overdose and in monitoring levels of codein e toensure appropriate therapy.
A.3300 Digitoxin test system 2 A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements
obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin t o ensure
appropriate therapy.
A.3320 Digoxin test system 2 A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtai ned
by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate
therapy.
A.3350 Diphenylhydantoin test
system2 A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens.
Measurements obtained by this device are used in th e diagnosis and treatment of diphenylhydantoin overdose and in monitoring
levels of diphenylhydantoin to ensure appropriate therapy.
A.3360 Drug metabolizing enzyme
genotyping system.2 A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted
from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. Thi s
device is used as an aid in determining treatment choice and individualizin g treatment dose for therapeutics that are metabolized
primarily by the specific enzyme about which the system provides genotypic information.
A.3380 Ethosuximide test system 2 An ethosuximide test system is a device intended to measure ethosuximide concentrations, an antiepileptic drug, in human
specimens.
Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring level s
of ethosuximide to ensure appropriate therapy.
A.3450 Gentamicin test system 2 A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements
obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to
ensure appropriate therapy.
A.3520 Kanamycin test system 2 A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements
obtained by this device are used in the diagnosis and treatment of kanamyci n overdose and in monitoring levels of kanamycin to
ensure appropriate therapy.
A.3550 Lead test system 2 A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this dev ice
are used in the diagnosis and treatment of lead poisoning.
A.3555 Lidocaine test system 2 A lidocaine test system is a device intended to measure lidocaine, an antiarrhythmic and anticonvulsant drug, in serum and
plasma.
Measurements obtained by this device are used in the d iagnosis and treatment of lidocaine overdose or in monitoring levels of
lidocaine to ensure appropriate therapy.
A.3560 Lithium test system 2 A lithium test system is a device intended to measure the concentration of lithium (from the drug lithium carbonate) in serum or
plasma.Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with ment al
disturbances, such as manic-depressive illness.
A.3580 Lysergic acid diethylamide
(LSD) test system2 Alysergic acid diethylamide (LSD) test system is a device intended to measure lysergic acid diethylamide concentrations, a
hallucinogenic drug, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis an d
treatment of LSD use or overdose.
A.3590 Meprobamate test system 2 A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this
device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally- related
drug compounds (e.g., prodrugs).
A.3600 Mercury test system 1 A mercury test system is a device intended to measure mercury, a heavy metal, in human specimens. Measurements obtained by
this device are used in the diagnosis and treatment of mercury poisoning.
A.3610 Methamphetamine test
system2 A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in
serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use
or overdose.
A.3620 Methadone test system 2 A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine.
Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine
compliance with regulations in methadone maintenance treatment.
A.3630 Methaqualone test system 2 A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements
obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.
A.3640 Morphine test system 2 A morphine test system is a device intended to measure morphine, an addictive narcotic pain- relieving drug, and its analogs in
serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use
or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.
A.3645 Neuroleptic drugs
radioreceptor assay test
system2 A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor
blocking activity of neuroleptic drugs and their active metabolites.
A neuroleptic drug has anti- psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and
is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed
dosage level of such drugs.
A.3650 Opiate test system 2 An opiate test system is a device intended to measure any of the addictive narcotic pain- relieving opiate drugs in blood, serum,
urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharma cological actions. The
opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements
obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate
administration to ensure appropriate therapy.A.3652 Organophosphate test
system2 An organophosphate test system is a device inte nded to measure organophosphate metabolites quantitatively in human urine from
individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intende d
to aid in the confirmation and investigation of organophosphate exposure.
A.3660 Phenobarbital test system 2 A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative- hypnotic drug, in human
specimens. Measurements obtained by this device are used in the dia gnosis and treatment of phenobarbital use or overdose and in
monitoring levels of phenobarbital to ensure appropriate therapy.
A.3670 Phenothiazine test system 2 A phenothiazine test system is a device intended to measure any of the drugs of the phenothiazine class in human specimens.
Measurements obtained by this device are used in the diagnosis and treatment of phenothiazine use or overdose.
A.3680 Primidone test system 2 A primidone test system is a device intended to measure primidone, an antiepilepti c drug, in human specimens. Measurements
obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone t o
ensure appropriate therapy.
A.3700 Propoxyphene test system 2 A propoxyphene test system is a device intended to measure propoxyphene, a pain- relieving drug, in serum, plasma, and urine.
Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring
levels of propoxyphene to ensure appropriate therapy.
A.3750 Quinine test system 1 A quinine test system is a device intended to measure quinine, a fever-reducing and pain- relieving drug intended in the treatment
of malaria, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose
and malaria.
A.3830 Salicylate test system 2 A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti- inflammatory drugs
that includes aspirin , in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate
overdose and in monitoring salicylate levels to ensure appropriate therapy.
A.3840 Sirolimus test system. 2 A sirolimus test system is a device in tended to quantitatively determine sirolimus concentrations in whole blood. Measurements
are used as an aid in management of transplant patients receiving therapy with sirolimus.
A.3850 Sulfonamide test system 1 A sulfonamide test system is a device inten ded to measure sulfonamides, any of the antibacterial drugs derived from sulfanilamide,
in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of sulfonamide overdose and
in monitoring sulfonamide levels to ensure appropriate therapy.
A.3870 Cannabinoid test system 2 A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to
marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9- tetrahydrocannabinol, cannabidiol,
cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid
use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
A.3880 Theophylline test system 2 A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the
cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obta ined by this device are used inthe diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
A.3900 Tobramycin test system 2 A tobramycin test system is a device intended to measure tobramycin , an aminoglycoside antibiotic drug, in plasma and serum.
Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of
tobramycin to ensure appropriate therapy.
A.3910 Tricyclic antidepressant
drugs test system2 A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in ser um. The
tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, prot riptyline, and doxepin.
Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.
A.3950 Vancomycin test system 2 A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by
this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensur e
appropriate therapy.
A.9999 Others (Clinical Chemistry
and Clinical Toxicology
Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
B.0001 Human leukocyte antigen
typing system2 Human leukocyte antigen typing system is a device for human leukocyte antigen identification and typing.
B.0002 Blood component extractor 1,2 Blood component extractor is a device to separate blood components from centrifuged whole blood. Classification: (1) Automati c
blood component extractors in cluding sensors, weighting devices, are Class 2 devices; (2) Other devices are Class 1 devices.
B.1850 Dye and chemical solution
stains1 Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals i n solutions
used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
B.1860 Immunohistochemistry
reagents and kits1,2, 3 Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polycl onal or monoclonal antibodies
labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use
is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow
cytometry devices are not considered IHC's. Classification: (1) Class 1 devices used after the primary diagnosis of tumor
(neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and
eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.
(2) Class 2 devices intended for the detection and/or measurement of certain target analytes in order to provide prognostic or
predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC 's
provide the pathologist with information that is ordinarily reported as independent diagnostic in formation to the ordering clinician,
and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class 2
IHC's are those intended for semiquantitative measurement of an analyte, such as hormone rece ptors in breast cancer. (3) Class 3
devices intended for any use not described in paragraphs (1) or (2) of this section.B.1865 Cervical intraepithelial
neoplasia (CIN) test system2 A cervical intraepithelial neoplasia (CIN) test system is a device used to detect a biomarker associated with CIN in human tissues.
The device is indicated as an adjunct test and not to be used as a stand- alone device. The test results must be interpreted in the
context of the patient's clinical history including, but not limi ted to, prior and current cervical biopsy results, Papanicolaou (Pap)
test results, human papillomavirus (HPV) test results, and morphology on hematoxylin and eosin (H&E) stained sections. This
device is not intended to detect the presence of HPV .
B.1866 Lynch Syndrome test
systems2 Lynch syndrome test systems are in vitro diagnostic tests for use with tumor tissue to identify previously diagnosed cancer p atients
at risk for having Lynch syndrome.
B.2220 Synthetic cell and tissue
culture media and
components1 Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g.,
amino acids, vitamins, inorganic salts, etc.) that are essential for the survival and development of cell lines of humans a nd other
animals.
B.2260 Chromosome culture kit 1 A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's
5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital
chromosome abnormalities.
B.2280 Cultured animal and human
cells1 Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in
various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
B.2360 Mycoplasma detection
media and components1 Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia- like organisms
(PPLO), a common microbial contaminant in cell cultures.
B.2875 Balanced salt solutions or
formulations1 A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a
necessary component of mos t cell culture systems. This media component controls for pH, osmotic pressure, energy source, and
inorganic ions.
B.3700 Whole slide imaging system 2 The whole slide imaging system is an automated digital slide creation, viewing, and management system in tended as an aid to the
pathologist to review and interpret digital images of pathology slides.
B.4020 Analyte specific reagents 1,2,3 (a)Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands,
nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a
specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical
substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope when
they are sold to: (1) In vitro diagnostic manufacturers; or (2) Organizations that use the reagents to make tests for purposes
other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other
nonclinical laboratories.
(b)Classification: (1) Class 1; (2) Class 2 devices used in blood banking tests; (e.g., certain cytomegalovirus tests, serological
tests, and non-spirochete tests for treponema pallidum). (3) Class 3 (i) The analyte is intended as a component in a testintended for use in the diagnosis of a contagious condition that is highly likely to result in a fatal outcome and prompt,
accurate diagnosis offers the opportunity to mitigate the public health impact of the condition (e.g., human
immunodeficiency virus (HIV/AIDS)or tuberculosis (TB) severe acute respiratory syndrome (SARS) or hepatitis ; or (ii) The
analyte is intended as a component in a test intended for use in donor screening for conditions for which TFDA has
recommended or required testing in order to safeguard the blood supply or establish the safe use of blood and blood
products (e.g., tests for hepatitis or tests for identifying blood groups).
(c)Devices for the following intended use should refer to other TFDA regulations including. (1) Devices intended to use in the
diagnosis of a contagious condition that is highly likely to result in a fatal outcome and prompt, accurate diagnosis offers the
opportunity to miti-gate the public health. (2) devices intended as a component in a test intended for use in donor screening
for conditions for which TFDA has recommended or required testing in order to safeguard the blood supply or establish the
safe use of blood and blood products.
B.4400 Enzyme preparations 1 Enzyme preparations are products that are used in the histopathology laboratory for the following purposes: (1) To disaggregate
tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin) ;(2) To disaggregate fluid
specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction); (3) To aid in the selective
staining of tissue specimens (e.g., diastase for glycogen determination).
B.5200 Automated cell counter 2 An automated cell counter is a fully-automated or semi- automated device used to count red blood cells, white blood cells, or blood
platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These
devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the
erythrocyte mean corpuscular volume, the mean corpuscu lar hemoglobin, or the mean corpuscular hemoglobin concentration).
These devices may use either an electronic particle counting method or an optical counting method.
B.5220 Automated differential cell
counter2 An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device
may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or
other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method
utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
B.5240 Automated blood cell
diluting apparatus1 An automated blood cell diluting apparatus is a fully automated or semi- automated device used to make appropriate dilutions of a
blood sample for further testing.
B.5260 Automated cell-locating
device2 An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to
identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, s uch as the
arm.)
B.5300 Red cell indices device 2 A red cell indices device, us ually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume
(MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cellindices are used for the differential diagnosis of anemias.
B.5350 Microsedimentation
centrifuge1 A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.
B.5400 Coagulation instrument 2 A coagulation instrument is an automated or semiau tomated device used to determine the onset of clot formation for in vitro
coagulation studies.
B.5425 Multipurpose system for in
vitro coagulation studies2 A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and
its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
B.5600 Automated hematocrit
instrument2 An automated hematocrit instrument is a fully automated or semi- automated device which may or may not be part of a larger
system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as
anemia and erythrocytosis (an increase in the number of red cells).
B.5620 Automated hemoglobin
system2 An automated hemoglobin system is a fully automated or semi- automated device which may or may not be part of a larger system.
The generic type of device consists of the reagents, calibrators, controls, and instru mentation used to determine the hemoglobin
content of human blood.
B.5680 Automated heparin analyzer 2 An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with
protamine (a heparin-neutralizing substance) and determining photometrically the onset of air- activated clotting. The analyzer also
determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
B.5700 Automated platelet
aggregation system2 An au tomated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation
following the addition of an aggregating reagent to a platelet-rich plasma.
B.5800 Automated sedimentation
rate device1 An automated sedi mentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole
blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate de vice
is useful in monitoring treatment of a disease.
B.5850 Automated slide spinner 1 An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of
peripheral blood (blood circulating in one of the body's extremities, such as the arm).
B.5950 Blood volume measuring
device2 A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass,
plasma volume, and total blood volume.
B.6100 Bleeding time device 1 A bleeding time device is a device, usually employing two spring- loaded blades, that produces two small incisions in the patient's
skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, p rimarily the
platelets.
B.6150 Capillary blood collection
tube1 A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capill ary
action.B.6160 Manual blood cell counting
device1 A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.
B.6400 Hematocrit measuring
device1 A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to
measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal.
Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally hi gh total red cell
mass). The packed red cell volume is produced by centrifuging a given volume of blood.
B.6550 Occult blood test 2 An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such smal l quantities
that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
B.6600 Osmotic fragility test 1 An osmotic fragility test is a device used to determine the resistance of red blood cells t o hemolysis (destruction) in varying
concentrations of hypotonic saline solutions.
B.6650 Platelet adhesion test 2 A platelet adhesion test is a device used to determine in vitro platelet function.
B.6675 Platelet aggregometer 2 A platelet aggregometer i s a device, used to determine changes in platelet shape and platelet aggregation following the addition of
an aggregating reagent to a platelet rich plasma.
B.6700 Erythrocyte sedimentation
rate test1 An erythrocyte sedimentation rate test is a device th at measures the length of time required for the red cells in a blood sample to
fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An in creased
rate indicates tissue damage or inflammation.
B.7010 Flow cytometric test for
hematopoietic neoplasms2 A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells
in relation to the level of expression, antigen density, and distribu tion of specific cellular markers. These reagents are used as an
aid in the differential diagnosis or monitoring of hematologic abnormalities in patients having or suspected of having hematopoietic
neoplasms. The results should be interpreted by a patholog ist or equivalent professional in conjunction with other clinical and
laboratory findings.
B.7040 Adenosine triphosphate
release assay1 An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate (ATP) from pla telets
following aggregation. This measurement is made on platelet- rich plasma using a photometer and a luminescent firefly extract.
Simultaneous measurements of platelet aggregation and ATP release are used to evaluate platelet function disorders.
B.7060 Antithrombin III assay 2 An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with
the anticoagulant heparin to prevent coagulation). This determination is used to monitor the adminis tration of heparin in the
treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of
antithrombin III).
B.7100 Red blood cell enzyme
assay2 Red blood cell enzyme assay is a device used to mea sure the activity in red blood cells of clinically important enzymatic reactions
and their products, such as pyruvate kinase or 2,3- diphosphoglycerate. A red blood cell enzyme assay is used to determine the
enzyme defects responsible for a patient's hereditary hemolytic anemia.B.7140 Activated whole blood
clotting time tests2 An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombo sis
or pulmonary embolism by measuring the coagulation time of whole blood.
B.7250 Erythropoietin assay 2 A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of
red blood cells) in serum or urine. This assay provides diagnostic informati on for the evaluation of erythrocytosis (increased total
red cell mass) and anemia.
B.7275 Euglobulin lysis time tests 2 A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot form ed from
fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enz yme).
This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will d etect
accelerated fibrinolysis.
B.7280 Factor V Leiden DNA
mutation detection systems2 Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and
instruments which include polymerase chain re action (PCR) primers, hybridization matrices, thermal cyclers, imagers, and
software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.
B.7290 Factor deficiency test 2 A factor deficienc y test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect
coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor defic iency such
as hemophilia and the corresponding normal gene).
B.7300 Fibrin monomer
paracoagulation test2 A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated intravascula r
coagulation (nonlocalized clotting withi n a blood vessel) or in the differential diagnosis between disseminated intravascular
coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot).
B.7320 Fibrinogen/fibrin
degradation products assay2 A fibrinogen/fibrin degradation p roducts assay is a device used to detect and measure fibrinogen degradation products and fibrin
degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in
detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in
monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).
B.7340 Fibrinogen determination
system2 A fibrin ogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine
the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary
fibrinolysis (the dissolution of fibrin in a blood clot).
B.7360 Erythrocytic glucose-6-
phosphate dehydrogenase
assay2 An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-
phosphate dehydrogenase or of glucose-6- phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis
and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-
phosphate dehydrogenase defi ciency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin
reduction, catalase inhibition, and ultraviolet kinetics.
B.7375 Glutathione reductase assay 2 A glutathione reductase assay is a device used to determine th e activity of the enzyme glutathione reductase in serum, plasma, orerythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liver disease,
glutathione reductase deficiency, or riboflavin deficiency.
B.7400 Hemoglobin A2 assay 2 A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin
A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by d ecreased synthesis of one or more
types of hemoglobin polypeptide chains).
B.7415 Abnormal hemoglobin assay 2 An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to is olate
and identify abnormal genetically determined hemoglobin types.
B.7425 Carboxyhemoglobin assay 2 A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is
exposed to carbon monoxide) content of human blood as a n aid in the diagnosis of carbon monoxide poisoning. This measurement
may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.
B.7440 Electrophoretic hemoglobin
analysis system2 A hemoglobin electrophoresis analysis system is a device that electrophoretically separates and identifies normal and abnormal
hemoglobin types as an aid in the auxiliary diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a
hemoglobin abnormality.
B.7455 Fetal hemoglobin assay 2 A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F)
in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal
circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thala ssemia
(a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin po lypeptide chains).
The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or
radial immunodiffusion.
B.7470 Glycosylated hemoglobin
assay2 A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's
blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of
a patient's diabetes and to determine the proper insuli n dosage for a patient. Elevated levels of glycosylated hemoglobin indicate
uncontrolled diabetes in a patient.
B.7490 Sulfhemoglobin assay 2 A sulfhemoglobin assay is a device consisting of the reagents, calibrators, controls, and instrumentation used to determine the
sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia
(presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison). This measurement may b e made
using methods such as spectroscopy, colorimetry, spectrophotometry, or gasometry.
B.7500 Whole blood hemoglobin
assays2 A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometri c
instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device catego ry
does not include automated hemoglobin systems.
B.7525 Heparin assay 2 A heparin assay is a device used to determine the level o f the anticoagulant heparin in the patient's circulation. These assays arequantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or proced ures
based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
B.7660 Leukocyte alkaline
phosphatase test1 A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic
granulocytes (granular leukocytes stai nable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on
the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate c hronic
granulocytic leukemia (a malignan t disease characterized by excessive overgrowth of granulocytes in the bone marrow) and
reactions that resemble true leukemia, such as those occurring in severe infections and polycythemia (increased total red cell mass).
B.7675 Leukocyte peroxidase test 1 A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrop hils,
eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series ba se on
their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.
B.7695 Platelet factor 4
radioimmunoassay2 A platelet factor 4 radioimmunoassay is a device used to measure the le vel of platelet factor 4, a protein released during platelet
activation by radioimmunoassay. This device measures platelet activation, which may indicate a coagulation disorder, such as
myocardial infarction or coronary artery disease.
B.7720 Prothrombin consumption
test2 A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulatio n
process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for
thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.
B.7735 Prothrombin-proconvertin
test and thrombotest2 The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin ther apy (administration of a
coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a
diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders.
B.7750 Prothrombin time test 2 A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor defic iencies
in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients
receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or
pulmonary embolism).
B.7825 Sickle cell test 2 A sickle cell test is a device used t o determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle
cell diseases.
B.7875 Thrombin time test 2 A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the
evaluation of bleeding disorders.
B.7900 Thromboplastin generation
test1 A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
B.7925 Partial thromboplastin time
tests2 A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of th e effect
of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathwayB.8100 Bothrops atrox reagent 2 A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evalua tion
of disseminated intravascular coagulation (nonlocalized clotting in the blo od vessels) in patients receiving heparin therapy (the
administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinog enemia
(presence in the plasma of functionally defective fibrinogen).
B.8150 Calibrator for cell indices 2 A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an ins trument
intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean cor puscular hemoglobin
concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and o ther
characteristics have been precisely and accurately determined.
B.8165 Calibrator for hemoglobin
or hematocrit measurement2 A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a
hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material
whose characteristics have been precisely and accurately determined.
B.8175 Calibrator for platelet
counting2 A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platele t
counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been
precisely and accurately determined.
B.8185 Calibrator for red cell and
white cell counting2 A calibrator for red cell an d white cell counting is a device that resembles red or white blood cells and that is used to set instruments
intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other
characteristics have been precisely and accurately determined.
B.8200 Blood cell diluent 1 A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
B.8500 Lymphocyte separation
medium1 A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.
B.8540 Red cell lysing reagent 1 A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the coun ting of
white blood cells.
B.8625 Hematology quality control
mixture2 A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and
automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), p latelet count (PLT),
hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular
hemoglobin concentration (MCHC).
B.8950 Russell viper venom reagent 1 Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.
B.9050 Blood bank supplies 1 Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device inclu des
products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, cold packs for antisera
reagents, and tube stripper.B.9100 Empty container for the
collection and processing of
blood and blood
components2 An empty container for the collection and proces sing of blood and blood components is a device intended for medical purposes
that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for fu rther
processing.
B.9125 Vacuum-assisted blood
collection system1 A vacuum- assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for
subsequent reinfusion.
B.9145 Processing system for
frozen blood2 A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis
(disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells
and to deglycerolize and wash thawed cells for subsequent reinfusion.
B.9165 Blood establishment
computer software2 Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in
the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood
components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing
compatibility testing between donor and recipient, or by performing positive identif ication of patients and blood components at
the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device
intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
B.9175 Automated blood grouping
and antibody test system2 An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect
antibodies to blood group antigens.
B.9195 Blood mixing devices and
blood weighing devices1 A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A
blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are
collected.
B.9205 Blood and plasma warming
device2,3 (a)Nonelectromagnetic blood or plasma warming device. (1)Identification: A nonelectromagnetic blood and plasma warming
device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.
(2)Classification: Class 2.
(b)Electromagnetic blood and plasma warming device. (1)Identification. An electromagnetic blood and plasma warming device
is a device that employs elect romagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma
prior to administration. (2) Classification: Class 3.
B.9225 Cell-freezing apparatus and
reagents for in vitro
diagnostic use1 Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro
diagnostic use.
B.9245 Automated blood cell
separator2 An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw
whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, andreturn to the donor the remainder of the whole blood and blood components. The remainder of blood components i s intended for
transfusion or further manufacturing use. The device is operated by centrifugal or filtration separation principle. The bowl of the
separator is reusable or for single use.
B.9275 Blood bank centrifuge for in
vitro diagnostic use1 A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
B.9285 Automated cell-washing
centrifuge for immuno-
hematology2 An automated cell-washing centrifuge for immuno-hematology is a devi ce used to separate and prepare cells and sera for further
in vitro diagnostic testing.
B.9300 Automated Coombs test
systems2 An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red ce lls.
The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is
also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.
B.9320 Copper sulfate solution for
specific gravity
determinations1 A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a
potential donor's blood meets the required level (12.5 grams per 100 milli liters of blood for women and 13.5 grams per 100
milliliters of blood for men).
B.9400 Stabilized enzyme solution 2 A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood c ells
with cert ain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain,
bromelin, ficin, and trypsin.
B.9550 Lectins and protectins 1 Lectins and protectins are proteins derived from plants and lower animal s that cause cell agglutination in the presence of certain
antigens. These substances are used to detect blood group antigens for in vitro diagnostic purposes.
B.9575 Environmental chamber for
storage of platelet
concentrate1 An environmental chamber for storage of platelet concentrate is a device used to hold platelet- rich plasma within a preselected
temperature range.
B.9600 Potentiating media for in
vitro diagnostic use1 Potentiating media for in vitro diagnostic use is media, such as bovine albumin, that are used to suspend red cells and to enhance
cell reactions for antigen-antibody testing.
B.9650 Quality control kit for blood
banking reagents2 A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine
the specificity, potency, and reactivity of the cells and reagents used for blood banking.
B.9700 Blood storage refrigerator
and blood storage freezer1 A blood storage refrigerator and a blood storage freezer are devices int ended for medical purposes that are used to preserve blood
and blood products by storing them at cold or freezing temperatures.
B.9750 Heat-sealing device 1 A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bag s containing blood or blood
components.B.9875 Transfer set 2 A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to tr ansfer
blood or plasma from one container to another.
B.9900 Cord blood processing
system and storage
container2 A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord b lood.
This device is a functionally closed processing system that includes container s, other soft goods, and a centrifugation system for
cord blood concentration, and a final container for the cryopreservation and the storage of a cord blood product.
B.9999 Others (Hematology and
Pathology Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
C.0001 Enterovirus 71 serological
reagents2 Enterovirus 71 serological reagents are devices that consist of antigens and antisera used to detec t serum enterovirus antibodies in
serological tests. Additionally, some of these reagents consist of enterovirus antisera conjugated with a fluorescent dye whi ch used
to detect enterovirus from clinical specimens or from cultured isolates derived from clin ical specimens. The identification aids in
the diagnosis of enterovirus infections and provides epidemiological information on diseases caused by these viruses. Enterov irus
cause illnesses such as hand, foot and mouth diseases which in its serious form aff ect the central nervous system resulting in
encephalitis, viral meningitis or/and paralysis.
C.0002 Dengue virus serological
reagents2 Dengue virus serological reagents are devices that consist of antigens and/or antibodies for the detection of dengue a ntigens or
antibodies in serum of patients with signs or symptoms of dengue fever or dengue haemorrhagic fever . This detection aids in
diagnosis of diseases caused by dengue virus and provides epidemiological information on diseases caused by these viruses.
C.0003 Helicobacter spp.
serological reagents1 Helicobacter spp. serological reagents are devi ces consist of helicobacter antisera conjugated with a fluorescent dye which used
to detect Helicobacter pylori from clinical specimens or from cultured isola tes derived from clinical specimens. This identification
aids in the diagnosis of Helicobacter pylori infections and provides epidemiological information on diseases caused by these
viruses. Helicobacter pylori causes illnesses such as stomach ulcers, stom ach inflammation (gastritis) leading to upper abdominal
pain and bleeding.
C.0004 Human papillomavirus
serological reagents3 Human papillomavirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify
Human papillomavirus antibodies in serum. The identification aids in the diagnosis of cervical cancer, identifies immune stat us of
patients, and provides epidemiological information on diseases caused by these viruses.
C.0005 Plasmodium spp. serological
reagents2 Plasmodium spp. serological reagents are devices that consist of antigens and antisera used in serological tests to detect
Plasmodium antibodies in serum. Additionally, some of these reagents consist of Plasmodium antisera conjugated with a
fluorescent dye used to identify Plasmodium from clinical specimens. The identification aids in the diagnosis of Plasmodium
infections and provides epidemiological information on diseases caused by these viruses. Plasmodium cause human malaria
infections, whic h lead to fever, shiver, headache, muscle pain, arthralgia (joint pain). Untreated or unidentified diseases can cause
severe cerebral malaria and fatal renal failure.
C.1620 Antimicrobial susceptibility 2 An antimicrobial susceptibility test disc is a device that consists of antimicrobic- impregnated paper discs used to measure by atest disc disc-agar diffusion technique or a disc- broth elution technique the in vitro susceptibility of most clinically important bacterial
pathogens to antimicrobial agents. In the disc- agar diffusion technique, bacterial susceptibility is ascertained by directly measuring
the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc- broth elution technique is associated
with an automated rapid su sceptibility test system and employs a fluid medium in which susceptibility is ascertained by
photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid
medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
C.1640 Antimicrobial susceptibility
test powder2 An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified
amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these
therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
C.1645 Fully automated short-
term incubation cycle
antimicrobial susceptibility
system2 A fully automated short- term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of
antimicrobial agents i nto a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical
specimens. Test results obtained from short- term (less than 16 hours) incubation are used to determine the antimicrobial agent of
choice to treat bacterial diseases.
C.1700 Culture medium for
antimicrobial susceptibility
tests2 A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium
capable of supporting the growth of many o f the bacterial pathogens that are subject to antimicrobial susceptibility tests. The
medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performe d
in the treatment of disease.
C.2160 Coagulase plasma 1 Coagulase plasma is a device that consists of freeze- dried animal or human plasma that is intended for medical purposes to perform
coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the act ion of the enzyme
coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of diseas e
caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused
by these microorganisms.
C.2170 Automated colony counter 1 An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonie s
present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of
disease as a measure of the degree of bacterial infection.
C.2190 Automated image
assessment system for
microbial colonies on solid
culture media2 An automated image assessment system for microbial colonies on solid culture media is a system that is intended to assess the
presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenoty pic
and morphologic characteristics through analysis of two-dimensional digital images as an aid in diagnosis of infectious disease.
C.2300 Multipurpose culture
medium1 A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for m edical
purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additionalnutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseas es
caused by these microorganisms.
C.2320 Differential culture medium 1 A differential culture medium is a device that consists primarily of liquid biological materials intended for medical purpose s to
cultivate and identify different types of pathogenic microorganisms. The identification of these microorganisms is accomplished
by the addition of a specific biochemical component(s) to the medium. Microorganisms are identified by a visible change (e.g., a
color change) in a specific biochemical component(s) which indicates that specific metabolic reactions have occurred. Test results
aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.
C.2330 Enriched culture medium 1 An enriched culture me dium is a device that consists primarily of liquid or solid biological materials intended for medical purposes
to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a
relatively simple b asal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and
extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and a lso
provides epidemiological information on these diseases.
C.2350 Microbiological assay
culture medium1 A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended f or
medical purposes to cultivate selected test mic roorganisms in order to measure by microbiological procedures the concentration
in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of the se
substances is measured by their ability to promo te or inhibit the growth of the test organism in the inoculated medium. Test results
aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum . Tests
results may also be used to monitor the effects of the administration of certain antimicrobial drugs.
C.2360 Selective culture medium 1 A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical p urposes
to cultivate and identif y certain pathogenic microorganisms. The device contains one or more components that suppress the growth
of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the
diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
C.2390 Transport culture medium 1 A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viabilit y of
suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device
aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on t hese
diseases.
C.2410 Culture medium for
pathogenic Neisseria spp2 A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to
cultivate and identify pathogenic Neisseria spp. The ide ntification aids in the diagnosis of disease caused by bacteria belonging to
the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides
epidemiological information on these microorganisms.
C.2420 Oxidase screening test for 3 An oxidase screening test for gonorrhea is an in vitro device that consists of the articles intended to identify by chemical reaction,gonorrhea cytochrome oxidase, an oxidizing enzyme that is associated with certain bacteria including Neisseria gonorrhoeae. A sample of a
male's urethral discharge is obtained on a swab which is placed into a wetting agent containing an ingredient that will react with
cytochrome oxidase. When cytochrome oxidase is present, the swab turns a dark purple color within 3 minutes. Because it is
unlikely that cytochrome oxidase-positive organisms other than Neisseria gonorrhoeae are present in the urethral discharge of
males, the identification of cytochrome oxidase with this device indicates pre sumptive infection of the patient with the causative
agent of gonorrhea.
C.2450 Supplement for culture
media1 A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal cult ure
medium to produ ce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious
microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by
pathogenic microorganisms.
C.2480 Quality control kit for
culture media1 A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregna ted with
a specified, freeze-dried, viable microorganism, intended for medical purposes t o determine if a given culture medium is able to
support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and
also provides epidemiological information on these diseases.
C.2500 Microtiter diluting and
dispensing device1 A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilu te
very small quantities of biological or chemical reagents for use in various diagnostic procedures.
C.2560 Microbial growth monitor 1 A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a
liquid medium by measuring changes in light scattering properties, optical density, electr ical impedance, or by making direct
bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
C.2580 Gas-generating device 1 A gas-generating device is a device intended for medical purposes that produces predeterm ined amounts of selected gases to be
used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special
atmospheric requirements. The device aids in the diagnosis of disease.
C.2600 Wood's fluorescent lamp 1 A Wood's fluorescent lamp is a device intended for medical purposes to detect fluorescent materials (e.g., fluorescein pigment
produced by certain microorganisms) as an aid in the identification of these microorganisms. The device aids in the d iagnosis of
disease.
C.2660 Microorganism
differentiation and
identification device1 A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or m ore
components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test
reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganism s.
The device aids in the diagnosis of disease.
C.2850 Automated zone reader 1 An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth
inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc- agar diffusion antimicrobialsusceptibility tests. The device aids in decision making respecting the treatment of disease.
C.2900 Microbiological specimen
collection and transport
device1 A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to
preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and dur ing
their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device
aids in the diagnosis of disease caused by pathogenic microorganisms.
C.3010 Acinetobacter calcoaceticus
serological reagents1 Acinetobacter calcoaceticus serological reagents are devices that consist of Acinetobacter calcoaceticus antigens and antisera used
to identify this bacterium from cultured isolates derived from clinical specimens. The identification aids in the diagnosis o f disease
caused by the bacterium Acinetobacter calcoac eticus and provides epidemiological information on disease caused by this
microorganism. This organism becomes pathogenic in patients with burns or with immunologic deficiency, and infection can resu lt
in sepsis (blood poisoning).
C.3020 Adenovirus serological
reagents1 Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antib odies to
adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are
used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by
adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis
(inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).
C.3035 Arizona spp. serological
reagents1 Arizona spp. serological reagents are devices that consist of antisera and antigens used to identify Arizona spp. in cultured isolates
derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus
Arizona and provides epidemiological information on diseases caused by these microorganisms. Arizona spp. can cause
gastroenteritis (food poisoning) and sepsis (blood poisoning).
C.3040 Aspergillus spp. serological
reagents1 Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in var ious serological tests to identify
antibodies to Aspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the
genus Aspergillus. Aspergillosis is a disease marked by inflammatory granulomatous (tumor- like) lesions in the skin, ear, eyeball
cavity, nasal sinuses, lungs, and occasionally the bones.
C.3045 In vitro diagnostic device
for Bacillus spp. Detection2 An in vitro diagnostic device for Bacillus species (spp.) detection is a device used to dete ct and differentiate among Bacillus spp.
and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the
diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist o f Bacillus spp. antisera conjugated with
a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus- like organisms in clinical specimens;
bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susc eptibility to lysis by the phage; or antigens
used to identify antibodies to B. anthracis (anti-toxin and anti- capsular) in serum. Bacillus infections include anthrax (cutaneous,
inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non- gastrointestinal infections caused by
B. cereus.C.3050 Beta-glucan serological
assays.2 Beta-glucan serological assays are devices that consist of antigens or proteases used in serological assays. The device is intende d
for use for th e presumptive diagnosis of fungal infection. The assay is indicated for use in patients with symptoms of, or medical
conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep- seated
mycoses and fungemia.
C.3060 Blastomyces dermatitidis
serological reagents1 Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to Blastomyces dermatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungus
Blastomyces dermatitidis. Blastomycosis is a chronic granulomatous (tumor- like) disease, which may be limited to the skin or
lung or may be widely disseminated in the body resulting in lesions of the bones, liver, spleen, and kidneys.
C.3065 Bordetella spp. serological
reagents1 Bordetella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a
fluorescent dye, used in serological tests to identify Bordetella spp. from cultured isolates or directly from clinical specimens. The
identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Bordetella and provides epidemiological
information on these diseases. Bordetella spp. cause whooping cough (Bordetella pertussis) and other similarly contagious and
acute respiratory infections characterized by pneumonitis (inflammation of the lungs).
C.3085 Brucella spp. serological
reagents1 Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification of Brucella
spp. from cultured isolates derived from clinical specimens or to identify antibodies to Brucella spp. in serum. Additionally, some
of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Brucella spp.
directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnos is of
brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genus Brucella and provides epidemiological
information on diseases caused by these microorganisms.
C.3110 Campylobacter fetus
serological reagents1 Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify
Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the
diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus
is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain
membranes of the heart) and enteritis (inflammation of the intestines) in humans.
C.3120 Chlamydia serological
reagents1 Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibo dies to
chlamydia in serum. Additi onally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to
identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in
the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these
diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal
disease), and trachoma (a chronic disease of the eye and eyelid).
C.3125 Citrobacter spp. serological 1 Citrobacter spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Citrobacterreagents spp. from cultured isolates deriv ed from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria
belonging to the genus Citrobacter and provides epidemiological information on diseases caused by these microorganisms.
Citrobacter spp. have occasionally been associated with urinary tract infections.
C.3130 Clostridium difficile toxin
gene amplification assay2 A Clostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification and detect ion of
target sequences in Clostridium difficile toxin genes in fecal specimens from patients suspected of having Clostridium difficile
infection (CDI). The detection of clostridial toxin genes, in conjunction with other laboratory tests, aids in the clinical l aboratory
diagnosis of CDI caused by Clostridium difficile.
C.3135 Coccidioides immitis
serological reagents1 Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological tests to iden tify
antibodies to Coccidioides immit is in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus
belonging to the genus Coccidioides and provides epidemiological information on diseases caused by this microorganism. An
infection with Coccidioides immitis pro duces symptoms varying in severity from those accompanying the common cold to those
of influenza.
C.3140 Corynebacterium spp.
serological reagents1 Corynebacterium spp. serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify
Corynebacterium spp. from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belongin g to
the genus Corynebacterium and provides epidemiological information on diseases caused by these microor ganisms. The principal
human pathogen of this genus Corynebacterium diphtheriae, causes diphtheria. However, many other types of corynebacteria form
part of the normal flora of the human respiratory tract, other mucus membranes, and skin, and are either no npathogenic or have an
uncertain role.
C.3145 Coxsackievirus serological
reagents1 Coxsackievirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify a ntibodies
to coxsackievirus in serum. Addition ally, some of these reagents consist of coxsackievirus antisera conjugated with a fluorescent
dye that are used to identify coxsackievirus from clinical specimens or from tissue culture isolates derived from clinical sp ecimens.
The identification aids in t he diagnosis of coxsackievirus infections and provides epidemiological information on diseases caused
by these viruses. Coxsackieviruses produce a variety of infections, including common colds, meningitis (inflammation of brain
and spinal cord membranes), herpangina (brief fever accompanied by ulcerated lesions of the throat), and myopericarditis
(inflammation of heart tissue).
C.3165 Cryptococcus neoformans
serological reagents1 Cryptococcus neoformans serological reagents are devices that consist of ant igens used in serological tests to identify antibodies
toCryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye
(immunofluorescent reagents) and are used to identify Cryptococcus neofor mans directly from clinical specimens or from cultured
isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiolog ical
information on this type of disease. Cryptococcosis infections are foun d most often as chronic meningitis (inflammation of brain
membranes) and, if not treated, are usually fatal.C.3175 Cytomegalovirus serological
reagents2 Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serol ogical tests to identify
antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses
(principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytome galic inclusion
disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease
may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor dis ability, and mental
retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and
an infectious mononucleosis-like syndrome.
C.3200 Echinococcus spp.
serological reagents1 Echinococcus spp. serological reagents are devices that consist of Echinococcus spp. antigens and antisera used in serological tests
to identify antibodies to Echinococcus spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic
tapeworms belonging to the genus Echinococcus and provides epidemiological information on this disease. Echinococcosis is
characterized by the development of cysts in the liver, lung, kidneys, and other organs formed by the larva of the infecting
organisms.
C.3205 Echovirus serological
reagents1 Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibo dies to
echovirus in serum. Additionally, some of these reagents consist of echovirus antise ra conjugated with a fluorescent dye used to
identify echoviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identificat ion
aids in the diagnosis of echovirus infections and provides epidemiological informa tion on diseases caused by these viruses.
Echoviruses cause illnesses such as meningitis (inflammation of the brain and spinal cord membranes), febrile illnesses
(accompanied by fever) with or without rash, and the common cold.
C.3210 Endotoxin assay. 2 An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with
other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression
to severe sepsis.
C.3215 Device to detect and
measure non-microbial
analyte(s) for patients with
suspected sepsis2 A device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with
suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of
one or more non- microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when
used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
C.3220 Entamoeba histolytica
serological reagents1 Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serologi cal tests to identify
antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent
dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specim ens. The identification aids
in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba histolytica and provides epidemiological
information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing
disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.C.3225 Enterovirus nucleic acid
assay2 An enterovirus nucleic acid assay is a device that consists of primers, probes , enzymes, and controls for the amplification and
detection of enterovirus ribonucleic acid (RNA) in cerebrospinal fluid (CSF) from individuals who have signs and symptoms
consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests,
aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.
C.3235 Epstein-Barr virus
serological reagents1,2 Epstein-Barr virus serological reagents are devices that consist of antige ns and antisera used in serological tests to identify
antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein- Barr virus infections and provides
epidemiological information on diseases caused by these viruses. Epstein- Barr viruses are thought to cause infectious
mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and
postnasal carcinoma (cancer). Classification: (1) Class1 devices for diagnosis of infectious mononucleosis (2) Class 2 devices for
diagnosis, prognosis and treatment of Burkitt's lymphoma, postnasal carcinoma, and other cancer.
C.3240 Equine encephalomyelitis
virus serological reagents1 Equine encephalomyelitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to
identify anti bodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine
encephalomyelitis viruses and provides epi demiological information on these viruses. Equine encephalomyelitis viruses are
transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the br ain),
rash, acute arthritis, or hepatitis.
C.3250 Erysipelothrix rhusiopathiae
serological reagents1 Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used in serological tests to
identify Erysipelothrix rhusiopathiae from cultured isolates derived from c linical specimens. The identification aids in the
diagnosis of disease caused by this bacterium belonging to the genus Erysipelothrix. This organism is responsible for a variety of
inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry.
C.3255 Escherichia coli serological
reagents1 Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify
Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia
coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates
derived from clinical specimens. The identific ation aids in the diagnosis of diseases caused by this bacterium belonging to the
genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia
coli constitutes the greater part of the microorgan isms found in the intestinal tract in humans and is usually nonpathogenic, those
strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.
C.3270 Flavobacterium spp.
serological reagents1 Flavobacterium spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify
Flavobacteriuim spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of dise ase
caused by bacteria belonging to the genus Flavobacterium and provides epidemiological information on diseases caused by these
microorganisms. Most members of this genus are found in soil and water and, under certain conditions, may become pathogenic
to humans. Flavobacterium meningosepticum is highly virulent for the newborn, in whom it may cause epidemics of septicemia(blood poisoning) and meningitis (inflammation of the membranes of the brain) and is usually attributable to contaminated hos pital
equipment.
C.3280 Francisella tularensis
serological reagents1 Francisella tularensis serological reagents are devices that consist of antigens and antisera used in serological tests to id entify
antibodies to Francisella tularensis in serum or to identify Francisel la tularensis in cultured isolates derived from clinical
specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent
reagents) used to identify Francisella tularensis directly from clinical speci mens. The identification aids in the diagnosis of
tularemia caused by Francisella tularensis and provides epidemiological information on this disease. Tularemia is a di sease
principally of rodents, but may be transmitted to humans through handling of infec ted animals, animal products, or by the bites of
fleas and ticks. The disease takes on several forms depending upon the site of infection, such as skin lesions, lymph node
enlargements, or pulmonary infection.
C.3290 Gonococcal antibody test
(GAT)3 A gon ococcal antibody test (GAT) is an in vitro device that consists of the reagents intended to identify by immunochemical
techniques, such as latex agglutination, indirect fluorescent antibody, or radioimmunoassay, antibodies to Neisseria gonorrhoeae
in sera of asymptomatic females at low risk of infection. Identification of antibodies with this device may indicate past or present
infection of the patient with Neisseria gonorrhoeae.
C.3300 Haemophilus spp.
serological reagents1 Haemophilus spp. serological r eagents are devices that consist of antigens and antisera, including antisera conjugated with a
fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture
isolates derived from clinic al specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the
genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often
caused by Haemophilus spp. incl ude pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious
form of conjunctivitis (inflammation of eyelid membranes).
C.3305 Herpes simplex virus
serological reagents2,3 Herpes simplex virus serological assays are devi ces that consist of antigens and antisera used in various serological tests to identify
antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjug ated
with a fluorescent dye (immunofluoresc ent assays) used to identify herpes simplex virus directly from clinical specimens or tissue
culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simpl ex
viruses and provides epidemiologica l information on these diseases. Herpes simplex viral infections range from common and mild
lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus
infections range from a mild infection to a severe generalized disease with a fatal outcome. Classification: (1) Class 2 devices for
HSV1 and/or HSV2 identification ;(2) Class 3 devices for other types of HSV identification.
C.3309 Herpes virus nucleic acid-
based cutaneous and
mucocutaneous lesion panel2 A herpes virus nucleic acid- based cutaneous and mucocutaneous lesion panel is a qualitative in vitro diagnostic device intended
for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesio n samples from
symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as t hesole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples.
C.3320 Histoplasma capsulatum
serological reagents1 Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to id entify
antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of Histoplasma capsulatum antisera
conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Histoplasma capsulatum from clinical specimens
or cultured isolates derived from clinical specimens. T he identification aids in the diagnosis of histoplasmosis caused by this
fungus belonging to the genus Histoplasma and provides epidemiological information on the diseases caused by this fungus.
Histoplasmosis usually is a mild and often asymptomatic respi ratory infection, but in a small number of infected individuals the
lesions may spread to practically all tissues and organs.
C.3328 Influenza virus antigen
detection test system2 An influenza virus antigen detection test system is a device for qualitati ve (rapid screening) detection of influenza virus infection
directly from clinical specimens of patients with respiratory symptoms and signs. The test aids in the diagnosis of influenza
infection and provides epidemiological information on influenza. Due t o the propensity of the virus to mutate, new strains emerge
over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to
an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health
implications.
C.3330 Influenza virus serological
reagents1 Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibo dies
to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information o n
influenza. Influenza is an acute respiratory tract disease, which is often epidemic. This classification does not include de vices for
qualitative (rapid screening) detection of influenza virus infection directly from clinical specimens of patients with respir atory
symptoms and signs.
C.3332 Reagents for detection of
specific novel influenza A
viruses.2 Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification
test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids
in the diagnosis o f influenza caused by specific novel influenza A viruses in patients with clinical risk of infection with these
viruses, and also aids in the presumptive laboratory identification of specific novel influenza A viruses to provide epidemio logical
information on influenza. These reagents include primers, probes, and specific influenza A virus controls.
C.3336 John Cunningham Virus
serological reagents2 John Cunningham Virus serological reagents are devices that consist of antigens and antisera used in serolo gical assays to identify
antibodies to John Cunningham Virus in serum and plasma. The identification aids in the risk stratification for the developme nt of
progressive multifocal leukoencephalopathy in multiple sclerosis and Crohn's disease patients underg oing natalizumab therapy.
These devices are for adjunctive use, in the context of other clinical risk factors for the development of progressive multif ocal
leukoencephalopathy.
C.3340 Klebsiella spp. serological
reagents1 Klebsiella spp. serological reag ents are devices that consist of antigens and antisera, including antisera conjugated with a
fluorescent dye (immunofluorescent reagents), that are used in serological tests to identify Klebsiella spp. from cultured isolatesderived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus
Klebsiella and provides epidemiological information on these diseases. These organisms can cause serious urinary tract and
pulmonary infections, particularly in hospitalized patients.
C.3350 Leptospira spp. serological
reagents1 Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies
to Leptospira spp. in serum or identify Leptospi ra spp. from cultured isolates derived from clinical specimens. Additionally, some
of these antisera are conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify Leptospira spp. directly
from clinical specimens. The identification aids in the diagnosis of leptospirosis caused by bacteria belonging to the genus
Leptospira and provides epidemiological information on this disease. Leptospira infections range from mild fever- producing
illnesses to severe liver and kidney involvement producing hemorrhage and dysfunction of these organs.
C.3355 Listeria spp. serological
reagents1 Listeria spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Listeria spp.
from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Listeria spp. antisera
conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Listeria spp. directly from clinical specimens.
The identification aids in the diagnosis of listeriosis, a disease caused by bacteria belonging to the genus Listeria, and provides
epidemiological information on diseases caused by these microorganisms. Listeria monocytogenes, the most common human
pathogen of this genus, caus es meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the
brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection i n
pregnant women that results in a high mortality rate for infants before or after birth.
C.3360 Lymphocytic
chorimeningitis virus
serological reagents1 Lymphocytic choriomeningitis virus serological reagents are devices that consist of antigens and antisera used in serological tests
toidentify antibodies to lymphocytic choriomeningitis virus in serum. The identification aids in the diagnosis of lymphocytic
choriomeningitis virus infections and provides epidemiological information on diseases caused by these viruses. Lymphocytic
choriome ningitis viruses usually cause a mild cerebral meningitis (inflammation of membranes that envelop the brain) and
occasionally a mild pneumonia, but in rare instances may produce severe and even fatal illnesses due to complications from
cerebral meningitis and pneumonia.
C.3365 Multiplex nucleic acid assay
for identification of
microorganisms and
resistance markers from
positive blood cultures2 A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cu ltures is a
qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures th at test
positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism
identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in
conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and
susceptibility testing.
C.3370 Mycobacterium tuberculosis
immunofluorescent reagents1 Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye
used to identify Mycobacte rium tuberculosis directly from clinical specimens. The identification aids in the diagnosis oftuberculosis and provides epidemiological information on this disease. Mycobacterium tuberculosis is the common causative
organism in human tuberculosis, a chro nic infectious disease characterized by formation of tubercles (small rounded nodules) and
tissue necrosis (destruction), usually occurring in the lung.
C.3372 Nucleic acid-based in vitro
diagnostic devices for the
detection of Mycobacterium
tuberculosis complex in
respiratory specimens2 Nucleic acid- based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens
are qualitative nucleic acid-based in vitro diagnostic devices intended to detect Mycobacteri um tuberculosis complex nucleic acids
extracted from human respiratory specimens. These devices are non- multiplexed and intended to be used as an aid in the diagnosis
of pulmonary tuberculosis when used in conjunction with clinical and other laboratory fin dings. These devices do not include
devices intended to detect the presence of organism mutations associated with drug resistance. Respiratory specimens may incl ude
sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.
C.3373 Nucleic acid-based in vitro
diagnostic devices for the
detection of Mycobacterium
tuberculosis complex
(MTB-complex) and the
genetic mutations associated
with MTB-complex
antibiotic resistance in
respiratory specimens2 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB- complex) and the
genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens are qualitative nucleic acid- based
devices that detect the presence of MTB-complex- associated nucleic acid sequences in respiratory samples. These devices are
intended to aid in the diagnosis of pulmonary tuberculosis and the selection of an initial treatment regimen when used in
conjunction with clinical findings and other laboratory results. These devices do not provide confirmation of antibiotic
susceptibility since other mechanisms of resistance may exist that may be associated with a lack of clinical response to trea tment
other than those detected by the device.
C.3375 Mycoplasma spp.
serological reagents1 Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated
with a fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The
identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological
information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the
urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range
from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.
C.3380 Mumps virus serological
reagents1 Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus
in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reage nts)
used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification
aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease,
particularly in children, charac terized by an enlargement of one or both of the parotid glands (glands situated near the ear), although
other organs may also be involved.C.3390 Neisseria spp. Direct
serological test reagents2 Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify
Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a
fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical
specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic
cerebrospinal meningitis, meningococcal diseas e, and gonorrhea, and also provides epidemiological information on diseases
caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect
methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
C.3395 Norovirus serological
reagents2 Norovirus serological reagents are devices that consist of antigens and antisera used in serological tests to detect the pres ence of
norovirus antigens in fecal samples. These devices aid in the diagnosis of norovirus infection in the setting of an individual patient
with symptoms of acute gastroenteritis when the individual patient is epidemiologically linked to other patients with symptom s of
acute gastroenteritis and/or aid in the id entification of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting
of epidemiologically linked patients with symptoms of acute gastroenteritis.
C.3400 Parainfluenza virus
serological reagents1 Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and pr ovides
epidemiological informatio n on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses
ranging from the common cold to pneumonia.
C.3402 Plasmodium species antigen
detection assays2 A Plasmodium species antigen detection assay is a device that employs antibodies for the detection of specific malaria parasite
antigens, including histidine-rich protein- 2 (HRP2) specific antigens, and pan malarial antigens in human whole blood. These
devices are used for testing specimens from individuals who have signs and symptoms consistent with malaria infection. The
detection of these antigens aids in the clinical laboratory diagnosis of malaria caused by the four malaria species capable o f
infecting humans: Plasmodium falciparum, Plasmodium vivax, Plasmodium oval, and Plasmodium malariae, and aids in the
differential diagnosis of Plasmodium falciparum infections from other less virulent Plasmodium species. The device is intended
for use in conjunction with other clinical laboratory findings.
C.3405 Poliovirus serological
reagents1 Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antib odies to
poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conju gated with a fluorescent dye
(immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived fr om
clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on
this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resul ting in
atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.
C.3410 Proteus spp. (Weil-Felix)
serological reagents1 Proteus spp. (Weil- Felix) serological reagents are devices that consist of antigens and antisera, including antisera conjugated with
a fluorescent dye (immunofluorescent reagents), derived from the bacterium Proteus vulgaris used in agglutination tests (a specifictype of antigen-antibody reaction) for the detection of antibodies to rickettsia (virus- like bacteria) in serum. Test results aid in the
diagnosis of diseases caused by bacteria belonging to the genus Rickettsiae and provide epidemiological information on these
diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans
characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
C.3415 Pseudomonas spp.
serological reagents1 Pseudomonas spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a
fluorescent dye (immunofluorescent reagents), used to identify Pseudomonas spp. from clinical specimens or from cultured isolates
derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus
Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital- acquired infections, and has been associated with urinary
tract infections, eye infections, burn and wound infections, blood poisoning, abscesses, and meningitis (inflammation of brai n
membranes). Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.
C.3460 Rabiesvirus
immunofluorescent reagents2 Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye use d to
identify rabiesvirus in specimens taken from suspec ted rabid animals. The identification aids in the diagnosis of rabies in patients
exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the cent ral
nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.
C.3470 Reovirus serological
reagents1 Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibod ies to
reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides epidemiological information o n
diseases caused by these viruses. Reoviruses are thought to cause only mild respiratory and gastrointestinal illnesses.
C.3480 Respiratory syncytial virus
serological reagents1 Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to respiratory syncytial virus in serum. Additionally, som e of these reagents consist of respiratory syncytial virus antisera
conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinic al
specimens or from tissue culture isolates derived from clini cal specimens. The identification aids in the diagnosis of respiratory
syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytia l
viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.
C.3490 Rhinovirus serological
reagents1 Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antib odies to
rhinovirus in serum. The identification aids in the diagnosis of rhinovirus infections and provides epidemiological information on
diseases caused by these viruses. Rhinoviruses cause common colds.
C.3500 Rickettsia serological
reagents1 Rickettsia serological rea gents are devices that consist of antigens and antisera used in serological tests to identify antibodies to
rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye
(immunofluorescent reage nts) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis
of diseases caused by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these
diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humanscharacterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
C.3510 Rubella virus serological
reagents2 Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies
to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune
status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected
in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).
C.3520 Rubeola (measles) virus
serological reagents1 Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to i dentify
antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides ep idemiological information
on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particular ly in
children, characterized by a confluent and blotchy rash.
C.3550 Salmonella spp. serological
reagents1 Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella
spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonello sis caused by
bacteria belonging to the genus Salmonella and provides epidemiological information on this disease. Salmonellosis is
characterized by high grade fever ("enteric fever"), severe diarrhea, and cramps.
C.3600 Schistosoma spp.
serological reagents1 Schistosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to Schistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused by parasitic fla tworms
of the genus Schistosoma. Schistosomiasis is characterized by a variety of acute and chronic infections. Acute infection is marked
by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe and are caused by fibrous degeneration o f tissue
around deposited eggs of the parasite in the liver, lungs, and central nervous system. Schistosomes can also cause schistosom e
dermatitis (e.g., swimmer's itch), a skin disease marked by intense itching.
C.3630 Serratia spp. serological
reagents1 Serratia spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Serratia spp.
from cultured isolates. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Serratia and
provides epidemiological information on these diseases. Serratia spp. are occasionally associated with gastroenteritis (food
poisoning) and wound infections.
C.3660 Shigella spp. serological
reagents1 Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent
dye (immunofluorescent reagents), used in serological tests to identify Shigella spp. from cultured isolates. The identification aids
in the diagnosis of shigellosis caused by bacteria belonging to the genus Shigella and provides epidemiological information on
this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.
C.3680 Sporothrix schenckii
serological reagents1 Sporothrix s chenckii serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to Sporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis caused by a fungus
belonging to the genus Sporothrix and provides epidemiological information on this disease. Sporothrichosis is a chronic tumorlike
infection primarily of the skin.C.3700 Staphylococcus aureus
serological reagents1 Staphylococcus aureus serological reagents are device s that consist of antigens and antisera used in serological tests to identify
enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the di agnosis
of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these
diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After
ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).
C.3720 Streptococcus spp.
exoenzyme reagents1 Streptococcus spp. exoenzyme reagents are devices used to identify antibodies to Streptococcus spp. exoenzyme in serum. The
identification aids in the diagnosis of disease caused by bacteria belonging to the genus Streptococcus and provides
epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, i mpetigo
(an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
C.3740 Streptococcus spp.
serological reagents1 Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding s treptococcal exoenzyme
reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates
derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus
Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infecti ons,
such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever,
and kidney disease.
C.3780 Toxoplasma gondii
serological reagents2 Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identif y
antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent
dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the
diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on
this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and unt reated
may lead to brain defects, bl indness, and death of an unborn fetus. The disease is characterized in children by inflammation of the
brain and spinal cord.
C.3820 Treponema pallidum
nontreponemal test reagents2 Treponema pallidum nontreponemal test reagents are devices that consist o f antigens derived from nontreponemal sources (sources
not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used
in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms
with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema
and provides epidemiological information on syphilis.
C.3830 Treponema pallidum
treponemal test reagents2 Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagent (stand ardized
reagents with which test results are compared), and is used in Fluorescent treponemal antibody absorption, FTA- ABS, Treponema
pallidum immobilization (T.P.I.) and other tests for other treponema to identify the treponemal antigen and antibody in the serum.
The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and providesepidemiological information on syphilis.
C.3850 Trichinella spiralis
serological reagents1 Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identi fy
antibodies to Trichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms
belonging to the genus Trichinella and provides epidemiological information on trichinosis. Trichinosis is caused by inge stion of
undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.
C.3860 Trichomonas vaginalis
nucleic acid assay2 A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enz ymes, and controls for the amplification
and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women
symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomo niasis in asymptomatic women. The
detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of
trichomoniasis caused by Trichomonas vaginalis.
C.3870 Trypanosoma spp.
serological reagents1 Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by paras itic
protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills,
headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion,
inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seri ously
affects the central nervous system and heart muscle.
C.3900 Varicella-zoster virus
serological reagents2 Varicella-zoster v irus serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella- zoster viruses and
provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of
children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-
zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses
present in latent form in the patient's body.
C.3930 Vibrio cholerae serological
reagents1 Vibrio cholerae serological reagents are devices that are used in the agglutination (an antigen- antibody clumping reaction) test to
identify Vibrio cholerae from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cholera
caused by the bacterium Vib rio cholerae and provides epidemiological information on cholera. Cholera is an acute infectious
disease characterized by severe diarrhea with extreme fluid and electrolyte (salts) depletion, and by vomiting, muscle cramps , and
prostration. If untreated, the severe dehydration may lead to shock, renal failure, cardiovascular collapse, and death.
C.3940 West Nile virus serological
reagents2 West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM
antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The
detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.
C.3946 Dengue virus nucleic acid 2 Dengue virus nucleic acid amplification test reagents are devices that consist of primers, probes, enzymes, and controls for theamplification test reagents amplification and detection of dengue virus serotypes 1, 2, 3, or 4 from viral ribonucleic acid (RNA) in human serum and plasma
from individuals who have signs and symptoms consistent with dengue (mild or severe). This test provides epidemiologic
information for surveillance of circulating dengue viruses.
C.3950 In vitro human
immunodeficiency virus
(HIV) drug resistance
genotype assay2 The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes together with
software for predicting drug resistance/susceptibility b ased on results obtained with these primers and probes. It is intended for
use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and t reating
HIV infection.
C.3955 Human immunodeficiency
virus (HIV) drug resistance
genotyping assay using next
generation sequencing
technology2 The HIV drug resistance genotyping assay using next generation sequencing (NGS) technology is an in vitro diagnostic device
intended for use in detecting HIV genomic m utations that confer resistance to specific antiretroviral drugs. The device is intended
to be used as an aid in monitoring and treating HIV infection.
C.3970 Device to detect and
identify microbial pathogen
nucleic acids in
cerebrospinal fluid2 A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro device intended for
the detection and identification of microbial- associated nucleic acid sequences from patients suspected of meningitis or
encephali tis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the
diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and labo ratory
findings.
C.3980 Respiratory viral panel
multiplex nucleic acid assay2 A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect
and identify multiple viral nucleic acids extracted fro m human respiratory specimens or viral culture. The detection and
identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the
diagnosis of respiratory viral infection when used in conj unction with other clinical and laboratory findings. The device is intended
for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype
H1 and Influenza A subtype H3; (3)Respiratory Sy ncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4)
Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.
C.3985 Device to detect and
identify microorganisms and
associated resistance marker
nucleic acids directly in
respiratory specimens2 A device to detect and identify microorganisms and associated resistance marker nucleic acids directly from respiratory speci mens
is an in vitro diagnostic device intended for the d etection and identification of microorganisms and associated resistance markers
in respiratory specimens collected from patients with signs or symptoms of respiratory infection. The device is intended to a id in
the diagnosis of respiratory infection in con junction with clinical signs and symptoms and other laboratory findings. These devices
do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist other than those detected b y the
device.
C.3990 Gastrointestinal 2 A gastrointestinal microorganism multiplex nucleic acid- based assay is a qualitative in vitro diagnostic device intended tomicroorganism multiplex
nucleic acid-based assaysimultaneously detect and identify multiple gastrointestinal microbial nucleic acids e xtracted from human stool specimens. The
device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin g enes.
The detection and identification of a specific gastrointestinal microbial nucleic ac id from individuals exhibiting signs and
symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clin ical
evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid- based assay also aids in the
detection and identification of acute gastroenteritis in the context of outbreaks.
C.4070 RNA Preanalytical Systems. 1,2 RNA Preanalytical Systems are devices intended to collect, store, and transport patient spec imens, and stabilize intracellular RNA
from the specimens, for subsequent isolation and purification of the intracellular RNA for RT- PCR used in in vitro molecular
diagnostic testing. Classification: (1) Class 1: Automatic specimen processing equipment. (2 ) Class 2: Reagents for isolation and
purification.
C.4100 Complement reagent 1 A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm- blooded animal
such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
C.4500 Immunoelectrophoresis
equipment1 Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein
molecules. Immunoel ectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various
proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated pr oteins are
then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate
complexes.
C.4520 Immunofluorometer
equipment1 Immunofluorometer equipment for clinical use with its electrical power supply is a devic e used to measure the fluorescence of
fluorochrome-labeled antigen- antibody complexes. The concentration of these complexes may be measured by means of reflected
light. A beam of light is passed through a solution in which a fluorochrome has been selective ly attached to serum protein antibody
molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts
light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a
recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen- antibody
complexes.
C.4540 Immunonephelometer
equipment1 Immunonephelometer equipment fo r clinical use with its electrical power supply is a device that measures light scattering from
antigen- antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light
passed through a solution is scatt ered by the particles in suspension. The amount of light is detected by a photodetector, which
converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter
or a recording chart. This electrical readout is called the light-scattering value and is used to measure the concentration of antigen-
antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.
C.4600 Ouchterlony agar plate 1 An ouchterlony agar plate for clinical use is a device containing an agar gel used to examine antigen- antibody reactions. Inimmunodiffusion, antibodies and antigens migrate toward each other through gel which originally contained neither of these
reagents. As the reagents come in contact with each other, they combine to form a precipitate that is trapped in the gel matr ix and
is immobilized.
C.4700 Automated fluorescence in
situ hybridization (FISH)
enumeration systems.2 An automated FISH e numeration system is a device that consists of an automated scanning microscope, image analysis system,
and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an
aid in the detection, c ounting and classification of cells based on recognition of cellular color, size, and shape, and in the detection
and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.
C.4750 Automated indirect
immunofluorescence
microscope and software-
assisted system2 An automated indirect immunofluorescence microscope and software- assisted system is a device that acquires, analyzes, stores,
and displays digital images of indirect immunofluorescent slides. It i s intended to be used as an aid in the determination of antibody
status in clinical samples. The device may include a fluorescence microscope with light source, a motorized microscope stage,
dedicated instrument controls, a camera, a computer, a sample pro cessor, or other hardware components. The software may include
fluorescent signal acquisition and processing software, data storage and transferring mechanisms, or assay specific algorithm s to
suggest results. A trained operator must confirm results generated with the device.
C.4800 Radial immunodiffusion
plate1 A radial immunodiffusion plate for clinical use is a device that consists of a plastic plate to which agar gel containing ant iserum is
added. In radial immunodiffusion, antigens migrate through ge l which originally contains specific antibodies. As the reagents
come in contact with each other, they combine to form a precipitate that is trapped in the gel matrix and immobilized.
C.4830 Rocket
immunoelectrophoresis
equipment1 Rocket immunoelectropho resis equipment for clinical use is a device used to perform a specific test on proteins by using a
procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migra te
through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket- shaped pattern, giving the name
to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.
C.5040 Albumin immunological test
system1 An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and
intestinal diseases.
C.5060 Prealbumin immunological
test system1 A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the
assessment of the patient's nutritional status.
C.5065 Human allotypic marker
immunological test system1 A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical
techniques the inherited human protein allotypic markers (such as nGm, nA2m, and Km allotypes) in serum and other body fluids .
The identification may be used while studying population genetics.
C.5080 Alpha-1-antichymotrypsin
immunological test system2 A alpha-1- antichymotrypsin immunological test system is a device that consists of the reagents used to measure by
immunochemical techniquesalpha-1-antichymotrypsin (a protein) in serum, other body fluids, and tissues. Alpha-1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.
C.5090 Antimitochondrial antibody
immunological test system2 An antimitochondrial antibody immunological test system is a devic e that consists of the reagents used to measure by
immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases
that produce a spectrum of autoantibodies (antibodies produced against the body' s own tissue), such as primary biliary cirrhosis
(degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).
C.5100 Antinuclear antibody
immunological test system2 An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents
(molecules present in the nucleus of a cell, such as ribonucleic ac id, deoxyribonucleic acid, or nuclear proteins). The measurements
aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim' s
own tissues), hepatitis (a liver disease), rheumatoid arthritis , Sjogren's syndrome (arthritis with inflammation of the eye, eyelid,
and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).
C.5110 Antiparietal antibody
immunological test system2 An antiparietal antibody im munological test system is a device that consists of the reagents used to measure by immunochemical
techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located
in the stomach th at produce a protein that enables vitamin B12to be absorbed by the body. The measurements aid in the diagnosis
of vitamin B12deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective
tissue diseases (diseases resulting when the body produces antibodies against its own tissues).
C.5120 Antismooth muscle
antibody immunological test
system2 An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The
measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases
(diseases resulting from antibodies produced against the body's own tissues).
C.5130 Alpha-1-antitrypsin
immunological test system2 A alpha-1- antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the alpha-1- antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the
diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1- antitrypsin deficiency has
been associated with pulmonary emphysema.
C.5150 Bence-Jones proteins
immunological test system2 A Bence- Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide
chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancer ous
conditions, there is a proliferation of one plasma cell (antibody- producing cell) with excess production of light chains of one
specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule
can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence- Jones proteins and
determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells),Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia
(cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).
C.5160 Beta-globulin
immunological test system1 A beta-globulin immunological test system is a device that cons ists of reagents used to measure by immunochemical techniques
beta globulins (serum protein) in serum and other body fluids. Beta -globulin proteins include beta - lipoprotein, transferrin,
glycoproteins, and complement, and are rarely associated with specific pathologic disorders.
C.5170 Breast milk immunological
test system1 A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical technique s
the breast milk proteins.
C.5180 Fecal calprotectin
immunological test system2 A fecal calprotectin immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively
measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended for in vitro
diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative c olitis,
and as an aid in differentiation of IBD from irritable bowel syndrome.
C.5200 Carbonic anhydrase B and C
immunological test system1 A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measur ements of
carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.
C.5210 Ceruloplasmin
immunological test system2 A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochem ical
techniques the ceruloplasmin (copper- transporting serum protein) in serum, other body fluids, or tissues. Measurements of
ceruloplasmin aid in the diagnosis of copper metabolism disorders.
C.5220 Cohn fraction II
immunological test system1 A Cohn fr action II immunological test system is a device that consists of the reagents that contain or are used to measure that
fraction of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used as a coprecipit ant
in radio immunoassay methods, as raw material for the purification of IgG subclasses, and to reduce nonspecific adsorption of
plasma proteins in immunoassay techniques. Measurement of these proteins aids in the diagnosis of any disease concerned with
abnormal levels of IgG gamma globulins such as agammaglobulinemia or multiple myeloma.
C.5230 Colostrum immunological
test system1 A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until
production of breast milk begins 1 to 5 days after childbirth.
C.5240 Complement components
immunological test system2 Acomplement components immu nological test system is a device that consists of the reagents used to measure by immunochemical
techniques complement components C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tissues.
Complement is a group of serum p roteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis
of immunologic disorders, especially those associated with deficiencies of complement components.
C.5250 Complement C1 inhibitor
(inactivator) immunological2 A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement C1inhibitor occurs normallytest system in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents).
Measurement of complement C1inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel
permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
C.5260 Complement C3b
inactivator immunological
test system2 A complement C3binactivator immunological test system is a device that consists of th e reagents used to measure by
immunochemical techniques the complement C3binactivator (a plasma protein) in serum. Complement is a group of serum proteins
that destroy infectious agents. Measurement of complement C3binactivator aids in the diagnosis of inherited antibody dysfunction.
C.5270 C-reactive protein
immunological test system2 A C- reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the C-reactive protein in serum and other body fluids. Measurement of C- reactive protein aids in evaluation of the
amount of injury to body tissues.
C.5320 Properdin factor B
immunological test system1 A properdin factor B immunological test system is a device that consists of the reagents u sed to measure by immunochemical
techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a
corresponding depression in the amount of properdin factor B in serum and other body fluids is evidence of the involvement of
the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destruction of
cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g.,
chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a
multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermat itis herpetiformis
(presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases in which
the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram-
negative bacteremia.
C.5330 Factor XIII, A, S,
immunological test system1 A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the factor XIII (a blood clotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the
diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.
C.5340 Ferritin immunological test
system2 A ferritin immunol ogical test system is a device that consists of the reagents used to measure by immunochemical techniques the
ferritin (an iron- storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting
iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
C.5350 Fibrinopeptide A
immunological test system2 A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the fibrinopeptide A (a blood- clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may
aid in the diagnosis and treatment of certain blood-clotting disorders.
C.5360 Cohn fraction IV
immunological test system1 A Cohn fract ion IV immunological test system is a device that consists of or measures that fraction of plasma proteins,
predominantly alpha- and beta-globulins, used as a raw material for the production of pure alpha- or beta- globulins. Measurement
of specific alpha- or beta- globulins aids in the diagnosis of many diseases, such as Wilson's disease (an inherited disease affectingthe liver and brain), Tangier's disease (absence of alpha-1- lipoprotein), malnutrition, iron deficiency anemia, red blood cell
disorders, and kidney disease.
C.5370 Cohn fraction V
immunological test system1 A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma containing
predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin levels may be depressed, e.g.,
nephrosis (disease of the kidney), proteinuria (protein in the urine), gastroenteropathy (disease of the stomach and small in testine),
rheumatoid arthritis, and viral hepatitis.
C.5380 Free secretory component
immunological test system1 A free secretory component immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques free secretory component (normally a portion of the secretory IgA a ntibody molecule) in body fluids.
Measurement of free secretory component (protein molecules) aids in the diagnosis or repetitive lung infections and other
hypogammaglobulinemic conditions (low antibody levels).
C.5400 Alpha-globulin
immunological test system1 An alpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the alpha- globulin (a serum protein) in serum and other body fluids. Measurement of alpha- globulin may aid in the
diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.
C.5420 Alpha-1-glycoproteins
immunological test system1 An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to meas ure by immunochemical
techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in
serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of colla gen (connective
tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.
C.5425 Alpha-2-glycoproteins
immunological test system1 An alpha-2-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the alpha-2-glycoproteins (a group of plasma proteins found in the alpha- 2 group when subjected to electrophoresis)
in serum and other body fluids. Measurement of alpha-2-glycoproteins aids in the diagnosis of some canc ers and genetically
inherited deficiencies of these plasma proteins.
C.5430 Beta-2-glycoprotein I
immunological test system1 A beta-2- glycoprotein I immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the beta-2-glycoprotein I (a serum protein) in serum and other body fluids. Measurement of beta-2- glycoprotein I aids
in the diagnosis of an inherited deficiency of this serum protein.
C.5440 Beta-2-glycoprotein III
immunological test system1 A beta-2- glycoprotein III immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the beta-2-glycoprotein III (a serum protein) in serum and other body fluids. Measurement of beta-2- glycoprotein III
aids in the diagnosis of an inherited deficiency of this serum protein and a variety of other conditions.
C.5460 Haptoglobin immunological
test system1 A haptoglobin immunological test system is a device that consists of the reagents used to measure by immu nochemical techniques
the haptoglobin (a protein that binds hemoglobin, the oxygen- carrying pigment in red blood cells) in serum. Measurement of
haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and r elease hemoglobin)
related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.C.5470 Hemoglobin immunological
test system2 A hemoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the different types of free hemoglobin (the oxygen- carrying pigment in red blood cells) in blood, urine, plasma, or other body
fluids. Measurements of free hemoglobin aid in the diagnosis of various hematologic disorders, such as sickle cell anemia,
Fanconi's anemia (a rare inherited disease), aplastic anemia (bone marrow does not produce enough blood cells), and leukemia
(cancer of the blood-forming organs).
C.5490 Hemopexin immunological
test system1 A hemopexin immunological t est system is a device that consists of the reagents used to measure by immunochemical techniques
the hemopexin (a serum protein that binds heme, a component of hemoglobin) in serum. Measurement of hemopexin aids in the
diagnosis of various hematologic dis orders, such as hemolytic anemia (anemia due to shortened in vivo survival of mature red
blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia.
C.5500 Hypersensitivity
pneumonitis immunological
test system2 A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the immunoglobulin antibodies in serum which react specifically with organic dust derived from
funga l or animal protein sources. When these antibodies react with such dusts in the lung, immune complexes precipitate and
trigger an inflammatory reaction (hypersensitivity pneumonitis). Measurement of these immunoglobulin G antibodies aids in the
diagnosis of hypersensitivity pneumonitis and other allergic respiratory disorders.
C.5510 Immunoglobulins A, G, M,
D, and E immunological
test system2 An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these
immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
C.5520 Immunoglobulin G (Fab
fragment specific)
immunological test system1 An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measu re
by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in
urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of
lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia
(increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).
C.5530 Immunoglobulin G (Fc
fragment specific)
immunological test system1 An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure
by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of
immunoglobulin G antibodies ) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in
the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.
C.5540 Immunoglobulin G (Fd
fragment specific)
immunological test system1 An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measur e
by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of th e
immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma
antibody-forming cell abnormalities.
C.5550 Immunoglobulin (light 2 An immunoglobulin (ligh t chain specific) immunological test system is a device that consists of the reagents used to measure bychain specific)
immunological test systemimmunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other
body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody- forming cells. These free
light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the
various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody- forming cells),
lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large
immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.
C.5560 Lactic dehydrogenase
immunological test system1 A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemi cal
techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety
of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart
disease), and some forms of leukemia (cancer of the blood- forming organs). However, the diagnostic usefulness of this device is
limited because of the many conditions known to cause increased lactic dehydrogenase levels.
C.5570 Lactoferrin immunological
test system1 A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical technique s
the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breas t milk, other body fluids,
and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.
C.5580 Alpha-1-lipoprotein
immunological test system2 An alpha-1-lipoprotein immunological test system is a device tha t consists of the reagents used to measure by immunochemical
techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1- lipoprotein may aid
in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
C.5590 Lipoprotein X
immunological test system1 A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniq ues
lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of
obstructive liver disease.
C.5600 Low-density lipoprotein
immunological test system2 A low-density lipoprotein immunological test system is a device that consists of the reagents used to measu re by immunochemical
techniques the low-density lipoprotein in serum and other body fluids. Measurement of low- density lipoprotein in serum may aid
in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.
C.5620 Alpha-2-macroglobulin
immunological test system2 An alpha-2- macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2- macroglobulin may aid in the
diagnosis of blood-clotting or clot lysis disorders.
C.5630 Beta-2-microglobulin
immunological test system2 A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2- microglobulin
aids in the diagnosis of active rheumatoid arthritis and kidney disease.
C.5640 Infectious mononucleosis
immunological test system2 An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, andother body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.
C.5660 Multiple autoantibodies
immunological test system2 A multiple autoantibodies immunological test system is a d evice that consists of the reagents used to measure by immunochemical
techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measuremen t
of multiple autoantibodies aids in the diagnosis of autoimm une disorders (disease produced when the body's own tissues are injured
by autoantibodies).
C.5665 Aquaporin-4 autoantibody
immunological test system2 An Aquaporin-4 autoantibody immunological test system is a device that consists of reagents used to mea sure by immunochemical
techniques autoantibodies in human serum samples that react with Aquaporin- 4 (AQP4Ab). The measurements aid in the diagnosis
of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) in conjunction with other clinical,
laboratory, and radiological (e.g., magnetic resonance imaging) findings.
C.5670 Zinc transporter 8
autoantibody immunological
test system2 A zinc transporter 8 autoantibody immunological test system is a device that consists of reagents used t o measure, by
immunochemical techniques, the autoantibodies in human serum samples that react with Zinc Transporter 8 (ZnT8). The
measurements aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in conjunction with other clinica l
and laboratory findings.
C.5680 Myoglobin immunological
test system2 A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in
the rapid diagnosis of heart or renal disease.
C.5700 Whole human plasma or
serum immunological test
system1 A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by
immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis
of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple
myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.
C.5715 Plasminogen immunological
test system1 A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical tec hniques
the plasminogen (an inactive substance from which plasmin, a blood- clotting factor, is formed) in serum, other body fluids, and
tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.
C.5735 Prothrombin immunological
test system1 A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical technique s
the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenicall y competent (ability to react with protein
antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.
C.5750 Radioallergosorbent
(RAST) immunological test
system2 A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement o f
specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.
C.5760 Tryptase test system 2 A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnosti c use as
an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical andlaboratory findings.
C.5765 Retinol-binding protein
immunological test system1 A retinol-binding protein immunological test system is a device that consists of the reagents used to measure by i mmunochemical
techniques the retinol- binding protein that binds and transports vitamin A in serum and urine. Measurement of this protein may
aid in the diagnosis of kidney disease and in monitoring patients with kidney transplants.
C.5775 Rheumatoid factor
immunological test system2 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissue s. Measurement of
rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
C.5785 Anti-Saccharomyces
cerevisiae (S.cerevisiae)
antibody (ASCA) test
systems2 The Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system is an in vitro diagnostic device that consists of
the reagents used to measure, by immunochemical techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in human
serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.
C.5820 Systemic lupus
erythematosus
immunological test system2 A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-
stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of
nuclear double-stranded DNA antibodies aids in the diagnosis of SL E (a multisystem autoimmune disease in which tissues are
attacked by the person's own antibodies).
C.5830 Brain trauma assessment
test2 A brain trauma assessment test is a device that consists of reagents used to detect and measure brain injury biomarker s in human
specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with
other clinical information to assist in determining the need for head imaging per current standard of care.
C.5860 Total spinal fluid
immunological test system1 A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteins may aid in the diagnosis of multiple
sclerosis and other diseases of the nervous system.
C.5870 Thyroid autoantibody
immunological test system2 A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical
techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibo dies
may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroid itis), nontoxic
goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), an d
cancer of the thyroid.
C.5880 Transferrin immunological
test system2 A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques
the transferrin (an iron- binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of
transferrin levels aids in the diagnosis of malnut rition, acute inflammation, infection, and red blood cell disorders, such as iron
deficiency anemia.C.5890 Inter-alpha trypsin inhibitor
immunological test system1 An inter-alpha trypsin inhibitor immunological test system is a device that consists of t he reagents used to measure by
immunochemical techniques the inter-alpha trypsin inhibitor (a protein) in serum and other body fluids. Measurement of inter-
alpha trypsin inhibitor may aid in the diagnosis of acute bacterial infection and inflammation.
C.5900 Cystic fibrosis
transmembrane conductance
regulator (CFTR) gene
mutation detection system.2 The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and varia nts
in the CFTR gene. It is intend ed as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF),
carrier identification, and newborn screening. This device is not intended for stand- alone diagnostic purposes, prenatal diagnostic,
pre-implantation, or population screening.
C.5930 Newborn screening test for
severe combined
immunodeficiency disorder
(SCID)2 A newborn screening test for SCID is a device intended to measure T- cell receptor excision circle (TREC) DNA obtained from
dried blood spot specimens on filter paper using a polymerase chain reaction based test as an aid in screening newborns for SCID.
Presumptive positive results must be followed up by diagnostic confirmatory testing. This test is not intended for use as a d iagnostic
test, or for screening of SCID- like syndromes, such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen
for less acute SCID syndromes, such as leaky SCID or variant SCID.
C.5940 Autosomal recessive carrier
screening gene mutation
detection system2 Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used
for genotyping of clinically relevant variants in genomic DNA isolated from human specimens. The device is intended for
autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation,
cytogenetic, or biochemical testing.
C.5950 Genetic health risk
assessment system2 A genetic health risk assessment system is a quali tative in vitro molecular diagnostic system used for detecting variants in genomic
deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of
developing a disease. This device does not determine the person's overall risk of developing a disease.
C.6010 Tumor-associated antigen
immunological test system2 A tumor- associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively
measure, by immunochemical techniques, tumor- associated antigens in serum, plasma, urine, or other body fluids. This device is
intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or re sidual
disease.
C.6020 Immunomagnetic
circulating cancer cell
selection and enumeration
system2 An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes,
fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and
count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or
predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.
C.6030 AFP-L3% immunological
test system.2 An AFP- L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to
quantitatively measure, by immunochemical techniques, AFP and AFP- L3 subfraction in human serum. The device is intended for
in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocell ular
carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.C.6040 Gene expression profiling
test system for breast cancer
prognosis2 A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression
level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognos is of
previously diagnosed breast cancer.
C.6050 Ovarian adnexal mass
assessment score test system2 An ovarian/ adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a
single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for
adjunctiv e use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients
whose gynecologic surgery requires oncology expertise and resources.
C.6060 BCR-ABL quantitation test 2 A BCR-ABL quantitation test is identified as a reverse transcription-quantitative polymerase chain reaction (RT- qPCR) test for the
quantitation of BCR- ABL1 expressed on the International Scale (IS) and control transcripts in total RNA from whole blood of
diagnosed t (9;22) positive chronic myeloid leukemia (CML) patients during monitoring of treatment with tyrosine kinase
inhibitors. This test is not intended for the diagnosis of CML.
C.6080 Next generation sequencing
(NGS) based tumor
profiling test2 A next generation sequencing ( NGS) based tumor profiling test is a qualitative in vitro diagnostic test intended for NGS analysis
of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in t he
management of previously diagnosed cancer patients by qualified health care professionals.
C.9999 Others(Immunology and
Microbiology Device)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
D.1040 Powered algesimeter 2 A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after
administration of an anesthetic agent.
D.1075 Argon gas analyzer 2 An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's
ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.
D.1100 Arterial blood sampling kit 2 An arteria l blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas
determinations. The kit may include a syringe, needle, cork, and heparin.
D.1120 Indwelling blood
oxyhemoglobin
concentration analyzer3 An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen- carrying
capacity of hemoglobin in blood to aid in determining the patient's physiological status.
D.1150 Indwelling blood carbon
dioxide partial pressure
(PCO 2) analyzer2 An indwelling blood carbon dioxide partial pressure PCO 2analyzer is a device that consists of a catheter-tip PCO 2transducer (e.g.,
PCO 2electrode) and that is used to measure, in vivo, the partial pressure of carbon diox ide in blood to aid in determining the
patient's circulatory, ventilatory, and metabolic status.
D.1170 Indwelling blood hydrogen
ion concentration (pH)
analyzer2 An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter- tip pH electrode and that is
used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.D.1200 Indwelling blood oxygen
partial pressure (PO 2)
analyzer2 An indwelling blood oxygen partial pressure (PO 2) analyzer is a device that consists of a catheter-tip PO 2transducer (e.g., PO 2
electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory,
ventilatory, and metabolic status.
D.1400 Carbon dioxide gas analyzer 2 A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in
determining the patient's ventilatory, circulatory, and metabolic status . The device may use techniques such as chemical titration,
absorption of infrared radiation, gas chromatography, or mass spectrometry.
D.1430 Carbon monoxide gas
analyzer2 A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in
determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.
D.1500 Enflurane gas analyzer 2 An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.
D.1505 Ventilatory electrical
impedance tomograph2 A ventilatory electrical impedance tomograph is a non-invasive, non- radiological ventilatory device that provides an assessment
of local impedance variation within a cross-section of a patient's thorax.
D.1575 Gas collection vessel 1 A gas collection vessel is a container- like device intended to collect a patient's exhaled gases for subsequent analysis. It does not
include a sampling pump.
D.1620 Halothane gas analyzer 2 A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The devi ce
may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.
D.1640 Helium gas analyzer 2 A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function
testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.
D.1670 Neon gas analyzer 2 A neon gas analyzer is a device intended to measure the concentration of neon in a gas mixture exhaled by a patient. The devi ce
may use techniques such as mass spectrometry or thermal conductivity.
D.1690 Nitrogen gas analyzer 2 A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determin ing a
patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.
D.1700 Nitrous oxide gas analyzer 2 A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The
device may use techniques such as infrared absorption or mass spectrometry.
D.1720 Oxygen gas analyzer 2 An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as
mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also i ncludes
paramagnetic analyzers.
D.1730 Oxygen uptake computer 2 An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include
components for determining expired gas volume and composition.
D.1750 Pressure plethysmograph 2 A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure
changes while the patient is in an airtight box.D.1760 V olume plethysmograph 2 A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.
D.1780 Inspiratory airway pressure
meter2 An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient 's airway during
maximal inspiration.
D.1800 Rhinoanemometer 2 A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and different ial
pressure across, a patient's nasal passages.
D.1840 Diagnostic spirometer 2 A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a pat ient's
lungs.
D.1850 Monitoring spirometer 2 A monitoring spirometer is a device used to measure continuously a pati ent's tidal volume (volume of gas inhaled by the patient
during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the
evaluation of the patient's ventilatory status.
D.1860 Peak-flow meter for
spirometry2 A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.
D.1880 Pulmonary-function data
calculator2 A pulmonary-function data calculator is a device used to calculate pulmonary-function value s based on actual physical data
obtained during pulmonary-function testing.
D.1890 Predictive pulmonary-
function value calculator2 A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary- function values based on
empirical equations.
D.1900 Diagnostic pulmonary-
function interpretation
calculator2 A diagnostic pulmonary- function interpretation calculator is a device that interprets pulmonary study data to determine clinical
significance of pulmonary-function values.
D.1910 Esophageal stethoscope 1 An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart
and breath sounds.
D.1920 Esophageal stethoscope
with electrical conductors2 An esophagea l stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart
and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature
measurement.
D.1930 Stethoscope head 1 A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiol ogical
sounds.
D.1975 Water vapor analyzer 1 A water vapor analyzer is a device intended to measure th e concentration of water vapor in a patient's expired gases by using
techniques such as mass spectrometry.
D.2025 Ultrasonic air embolism
monitor2 An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It m ay use Doppler or other
ultrasonic principles.D.2300 Bourdon gauge flowmeter 1 A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to
sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.
D.2320 Uncompensated thorpe tube
flowmeter1 An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flo w
rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the
atmosphere.
D.2340 Compensated thorpe tube
flowmeter1 A compensated thorpe tube flowmeter is a device intended for medical purposes that is us ed to control and measure gas flow rate
accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.
D.2375 Breathing frequency
monitor2 A breathing (ventilatory) frequency monitor is a d evice intended to measure or monitor a patient's respiratory rate. The device may
provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This
device does not include apnea monitors.
D.2377 Apnea monitor 2 An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detecte d
breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other
physiological parameters linked to the presence or absence of adequate respiration.
D.2380 Nitric oxide analyzer 2 The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures durin g
administration of nitric oxide.
D.2385 Nitric dioxide analyzer 2 The nitrogen dioxide analyzer is a device intended to measure the concentration of nitrogen dioxide in respiratory gas mixtur es
during administration of nitric oxide.
D.2450 Lung water monitor 3 A lung water monitor is a device used to monitor the trend of fluid volume changes in a patient's lung by measuring changes i n
thoracic electrical impedance (resistance to alternating current) by means of electrodes placed on the patient's chest.
D.2480 Cutaneous carbon dioxide
(PcCO2) monitor2 A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH- sensitive glass electrode placed on a
patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide
tension as an adjunct to arterial carbon dioxide tension measurement.
D.2500 Cutaneous oxygen (PcO2)
monitor2 A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode ) placed on the
patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.
D.2550 Pneumotachometer 2 A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressur e
differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.
D.2600 Airway pressure monitor 2 An airway pressure monitor is a device used to measure the pressure in a patient's upper airway . The device may include a pressure
gauge and an alarm.
D.2610 Gas pressure gauge 1 A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas
pressure in a medical gas delivery system.D.2700 Pressure regulator 1 A pressure regulator is a device, often called a pressure- reducing valve, that is intended for medical purposes and that is used to
convert a medical gas pressure from a high variable pressure to a lower, more constant working p ressure. This device includes
mechanical oxygen regulators.
D.2775 Electrical peripheral nerve
stimulator2 An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a
patient to test the level of pharmacological effect of anesthetic drugs and gases.
D.2875 Differential pressure
transducer1 A differential pressure transducer is a two- chambered device intended for medical purposes that is often used during pulmonary
function testing. It g enerates an electrical signal for subsequent display or processing that is proportional to the difference in gas
pressures in the two chambers.
D.2885 Gas flow transducer 1 A gas flow transducer is a device intended for medical purposes that is used to co nvert gas flow rate into an electrical signal for
subsequent display or processing.
D.2900 Gas pressure transducer 1 A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical s ignal
for subsequent display or processing.
D.5090 Emergency airway needle 2 An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway
during upper airway obstruction.
D.5100 Nasopharyngeal airway 1 A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to
provide a patent airway.
D.5105 External negative pressure
airway aid2 An external negative pressure airway aid is a device that applies negative pressure to a patient's neck to aid in providing a patent
airway during procedures requiring anesthesia.
D.5110 Oropharyngeal airway 1 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
D.5115 Device to relieve acute
upper airway obstruction2 The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed
upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.
D.5120 Anesthesia conduction
catheter2 An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide
continuous regional anesthesia.
D.5130 Anesthesia conduction filter 2 An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anesthetics to
minimize particulate (foreign material) contamination of the injected fluid.
D.5140 Anesthesia conduction kit 2 An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The devic e may
contain syringes, needles, and drugs.
D.5150 Anesthesia conduction
needle2 An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
D.5160 Gas machine for anesthesia 2 (a) Gas machine for anesthesia. A gas machine for anesthesia is a device used to administer to a patient, con tinuously oror analgesia intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmet er,
vaporizer, ventilator, breathing circuit with bag, and emergency air supply.
(b) Gas machine for analgesia. A ga s machine for analgesia is a device used to administer to a patient an analgesic agent, such as
a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
D.5165 Nitric oxide administration
apparatus2 The nitric oxide administrat ion apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric
oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
D.5170 Laryngotracheal topical
anesthesia applicator2 A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.
D.5180 Rocking bed 2 A rocking bed is a device intended for temporary use to help patient v entilation (breathing) by repeatedly tilting the patient, thereby
using the weight of the abdominal contents to move the diaphragm.
D.5220 Blow bottle 1 A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a p atient. The patient blows into
the device to move a column of water from one bottle to another.
D.5240 Anesthesia breathing circuit 1 An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides
both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
D.5250 Breathing circuit circulator 2 A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is inte nded to circulate
anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space
and resistance in the breathing circuit.
D.5260 Breathing circuit bacterial
filter2 A breathing circuit bacter ial filter is a device that is intended to remove microbiological and particulate matter from the gases in
the breathing circuit.
D.5270 Breathing system heater 2 A breathing system heater is a device that is intended to warm breathing gases before they e nter a patient's airway. The device may
include a temperature controller.
D.5273 Positive airway pressure
delivery system2 A positive airway pressure delivery system is a noninvasive ventilatory device that delivers expiratory positive airway press ure
for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The
system may include a dedicated flow generator and a patient interface.
D.5280 Breathing tube support 1 A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).
D.5300 Carbon dioxide absorbent 1 A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that
is intended to remove carbon dioxide from the gases in the breathing circuit.
D.5310 Carbon dioxide absorber 1 A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a cont ainer
for carbon dioxide absorbent. It may include a canister and water drain.
D.5320 Reservoir bag 1 A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for br eathinggas and to assist, control, or monitor a patient's ventilation.
D.5330 Breathing gas mixer 2 A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of
gases that are to be breathed by a patient.
D.5340 Nasal oxygen cannula 1 A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.
D.5350 Nasal oxygen catheter 1 A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.
D.5375 Heat and moisture
condenser (artificial nose)1 A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically create d
opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
D.5400 Electroanesthesia apparatus 3 An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by
means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head.
D.5430 Gas-scavenging apparatus 2 A gas- scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's
breathing system, ventilator, or extracorporeal pump- oxygenator, and to conduct these gases out of the area by means of an exhaust
system.
D.5440 Portable oxygen generator 2 A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by mea ns of either a chemical
reaction or physical means (e.g., a molecular sieve).
D.5450 Respiratory gas humidifier 2 A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for
administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.
D.5454 High flow humidified
oxygen delivery device2 A high flow humidified oxygen delivery device is a device that delivers high flow oxygen with hu midification for patients who
are suffering from respiratory distress and/or hypoxemia.
D.5460 Therapeutic humidifier for
home use1 A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respir atory
therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes t he
vapor during normal respiration.
D.5470 Hyperbaric chamber 2 A hyperbaric chamber is a device that is intended to increas e the environmental oxygen pressure to promote the movement of
oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device
does not include topical oxygen chambers for extremities (I.5650).
D.5530 Flexible laryngoscope 1 A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal
tube.
D.5540 Rigid laryngoscope 1 A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
D.5550 Anesthetic gas mask 1 An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to d irect
anesthetic gases to the upper airway.
D.5560 Gas mask head strap 1 A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.D.5570 Nonrebreathing mask 1 A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one- way valves to prevent the
patient from rebreathing previously exhaled gases.
D.5580 Oxygen mask 1 An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
D.5590 Scavenging mask 1 A scavenging mask is a device positioned over a patient's nose to deliver anesthetic or analgesic gases to the upper airway a nd to
remove excess and exhaled gas. It is usually used during dentistry.
D.5600 Venturi mask 1 A venturi mask is a device containing an air- oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined
concentration and delivers the mixed gases to a patient.
D.5610 Membrane lung for long-
term pulmonary support3 A membrane lung for long-term pulmonary suppo rt is a device used to provide to a patient extracorporeal blood oxygenation for
longer than 24 hours.
D.5620 Breathing mouthpiece 1 A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or ther apeutic
respiratory devices.
D.5630 Nebulizer 2 A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered to lower respiratory tract of the
patient. This device may contain a baffle to generate homogeneous downsized a erosol. Heated, ultrasonic, gas, venturi, and
refillable nebulizers are included in this generic type of device.
D.5640 Medicinal nonventilatory
nebulizer (atomizer)1 A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray l iquid medication in aerosol form that are
delivered to upper respiratory tract of the patient.
D.5650 Esophageal obturator 2 An esophageal obturator is a device inserted through a patient's mouth to aid ventilation of the patient during emergency
resuscit ation by occluding (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea. The
device consists of a closed-end semirigid esophageal tube that is attached to a face mask.
D.5665 Powered percussor 2 A powered percusso r is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits
in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.
D.5675 Rebreathing device 1 A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonar y
function testing or for increasing minute ventilation.
D.5690 Incentive spirometer 2 An incentive spirometer is a device that i ndicates a patient's breathing volume or flow and that provides an incentive to the patient
to improve his or her ventilation.
D.5700 Nonpowered oxygen tent 1 A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain ox ygen delivered to the patient for
breathing. This generic type of device includes infant oxygen hoods.
D.5710 Electrically powered oxygen
tent2 An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electricall y powered unit,
administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device inclu des
the pediatric aerosol tent.D.5720 Bronchial tube 2 A bronchial tube is a device used to differentially intuba te a patient's bronchus (one of the two main branches of the trachea leading
directly to the lung) in order to isolate a portion of lung distal to the tube.
D.5730 Tracheal tube 2 A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
D.5740 Tracheal/bronchial
differential ventilation tube2 A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for an esthesia or
pulmonary function testing.
D.5750 Inflatable tracheal tube cuff 2 An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.
D.5770 Tracheal tube fixation
device1 A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings.
D.5780 Tube introduction forceps 1 Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patien t's
trachea.
D.5790 Tracheal tube stylet 1 A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
D.5800 Tracheostomy tube and tube
cuff2 A tracheostomy tube and tube cuff is a dev ice intended to be placed into a surgical opening of the trachea to facilitate ventilation
to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establi sh a seal
between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as
blood or vomit, or to provide a means for positive- pressure ventilation of the patient. This device is made of either stainless steel
or plastic.
D.5810 Airway connector 1 An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
D.5830 Autotransfusion apparatus 2 An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
D.5860 Pressure tubing and
accessories1 Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.
D.5870 Nonrebreathing valve 2 A nonrebreathing valve is a one- way valve that directs breathing gas flow to the patient and vents exhaled gases into the
atmosphere.
D.5880 Anesthetic vaporizer 2 An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
D.5895 Continuous ventilator and
accessories2 A continuous ventilator (respirator) and accessories is a device intended to mechanically control or assist patient breathing by
delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in
this generic type of device. Face masks intended to be used with continuous ventilators are included in this classification.
D.5905 Noncontinuous ventilator
(IPPB) and accessories2 A noncontinuous ventilator (intermittent positive pressure breathing- IPPB) and accessories are the device intended to deliver
intermittently an aerosol to a patient's lungs or to assist a patient's breathing. This device is intended to use with access ories such
as masks of noncontinuous ventilator.
D.5915 Manual emergency 2 A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratoryventilator support by means of a face mask or a tube inserted into a patient's airway.
D.5925 Powered emergency
ventilator2 A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a
face mask or a tube inserted into a patient's airway.
D.5935 External negative pressure
ventilator2 An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's
ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
D.5955 Intermittent mandatory
ventilation attachment2 An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneou s
breathing by a patient while providing mechanical ventilation at a preset rate.
D.5965 Positive end expiratory
pressure breathing
attachment2 A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate p ressure
in a patient's lungs above atmospheric pressure at the end of exhalation.
D.5975 Ventilator tubing 1 Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation o f the
patient.
D.5995 Tee drain (water trap) 1 A tee dra in (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy,
thereby preventing an increase in breathing resistance.
D.6250 Portable air compressor 2 A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other
respiratory devices.
D.6810 Tracheobronchial suction
catheter1 A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.
D.6885 Medical gas yoke assembly 1 A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply ga ses
for anesthesia or respiratory therapy. The device may include a particulate filter.
D.9999 Others(Anesthesiology
Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
E.0001 Cardiovascular stent 3 Cardiovascular stent is a tube device which is intended to permanent implanted in human vessel or artificial vessel. This device
provides mechanical support to maintain vessel patency. Depending on the placement mechanism, these devices include balloon-
expanding stents and self-expanding stents. Classification: (1) Class 2 devices intended to be placed in peripheral arteries. For
example renal stents, iliac stents, superficial femoral artery stents ;(2) Class 3 devices intended to be placed other than peripheral
arteries. For example, coronary stents, and carotid stents.
E.0002 Cardiovascular excimer
laser system3 Cardiovascular excimer laser system is intended for the photoablation or debulking of vascular lesion material (blockages, to tal
occlusions). This device is used with an atherectomy catheter and typically consists of an electrical unit with a display, controls,
and/or foot-switch and excimer laser generator.
E.0004 Heart preservation/transport 2 A heart preservation/transport system is a device designed to maintain donated heart in an almost physiological state until the heartsystem transplant to the recipient.
E.0005 Percutaneous transluminal
coronary angioplasty
(PTCA) catheter2,3 (a)Standard PTCA catheter (1) Identification: The distal balloon structure is filled with liquid pressure and has a single or dual
lumen shaft with a polymer balloon configuration for clinical use. The balloon is designed to expand to a specified diameter
and length at a specified pressure, depending on the rate of expansion and contraction and a defined burst pressure. The
balloon is marked with an opaque line to identify the position. It is suitable for balloon expansion therapy in coronary
arteries or bypass surgically implanted vascular stenoses to improve myocardial perfusion. It may also be used to treat acute
myocardial infarction, in-stent restenosis (ISR), and/or post-stenting dilatation.(2) Classification: Class 2.
(b)Cutting/scoring PTCA catheter (1) Identification: The balloon catheter has a cutting unit attached, which is used to restri ct the
lesion with a high pressure balloon. It is indicated for the treatment of coronary stenosis to improve myocardial perfusion a nd
may also be used to treat C-complex lesions or in-stent restenosis (ISR). (2) Classification: Class 3.
E.0006 Endovascular graft system 3 An endovascular graft system is a device partially or completely placed in the human or artificial blood vessels. This device is
intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access. This device is deployed
through the vessel circuit. Endovascular graft systems for aortic aneurysm treatment and arteriovenous (A V) dialysis access c ircuit
stenosis treatment are included in this classification.
E.0008 Percutaneous cardiac
ablation system2,3 A percutaneous cardiac ablation system is intended for cardiac ablation surgery. This system contains percutaneous cardiac ab lation
catheter, RF ablation generator, cryoablation system, cooling catheter and cooling pump. Catheter remote control system is n ot
included in this classification. Classification: (1) Class 2: RF ablation generator, cryoablation system, cooling catheter an d cooling
pump. (2) Class 3: percutaneous cardiac ablation catheter.
E.1025 Arrhythmia detector and
alarm3 The arrhythmia dete ctor and alarm device monitor an electrocardiogram and is designed to produce a visible or audible signal or
alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
E.1100 Blood pressure alarm 2 A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and
emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.
E.1110 Blood pressure computer 2 A blood pres sure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates
the systolic, diastolic, or mean pressure based on the input signal.
E.1120 Blood pressure cuff 2 A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and
deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
E.1130 Noninvasive blood pressure
measurement system2 A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or a ny
combination of the three pressures can be derived through the use of transducers placed on the surface of the body.
E.1140 Venous blood pressure
manometer2 A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or periphe ral
venous pressure.
E.1200 Diagnostic intravascular 2 An intravascular diagnostic c atheter is a device used to record intracardiac pressures, to sample blood, and to introduce substancescatheter into the heart and vessels. Included in this generic device are right-heart catheters, left- heart catheters, and angiographic catheters,
among others.
E.1210 Continuous flush catheter 2 A continuous flush catheter is an attachment to a catheter- transducer system that permits continuous intravascular flushing at a
slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.
E.1220 Electrode recording catheter
or electrode recording probe2 An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to
detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or
may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to- right heart shunt
determinations.
E.1230 Fiberoptic oximeter catheter 2 A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles
that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.
E.1240 Flow-directed catheter 2 A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
E.1250 Percutaneous catheter 2 A percutaneous catheter is a device tha t is introduced into a vein or artery through the skin using a dilator and a sheath (introducer)
or guide wire.
E.1251 Temporary catheter for
embolic protection during
transcatheter intracardiac
procedures2 This device is a single use percutaneous cathet er system that has (a) blood filter(s) at the distal end. This device is indicated for
use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent e mbolic
material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.
E.1255 Balloon aortic valvuloplasty
catheter2 A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to t reat stenosis
in the aortic valve when the balloon is expanded.
E.1270 Intracavitary phonocatheter
system2 An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated dev ice
that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart,
blood vessels, or body cavities.
E.1280 Steerable catheter 2 A steerable catheter is a catheter used for diagnostic and monitoring purposes w hose movements are directed by a steering control
unit.
E.1290 Steerable catheter control
system2 A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the
motion of the steerable catheter.
E.1300 Catheter cannula 2 A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid stru cture
which can be connected to a tube or connector.
E.1310 Vessel dilator for
percutaneous catheterization2 A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in t he
vessel, and which is then removed before sliding the catheter over the guide wire.E.1330 Catheter guide wire 2 A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing th e catheter
through a blood vessel.
E.1340 Catheter introducer 2 A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
E.1350 Catheter balloon repair kit 3 A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the m aterials,
such as glue and balloons, necessary to effect the repair or replacement.
E.1360 Trace microsphere 3 A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vei n and
trapped in the capillary bed for the purpose of studying blood flow within or to an organ.
E.1370 Catheter tip occluder 2 A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.
E.1380 Catheter stylet 2 A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.
E.1390 Trocar 2 A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
E.1415 Coronary vascular
physiologic simulation
software device2 A coronary vascular physiologic simulation software device is a device that provides simulated functional assessment of blood
flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated
metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, and myocardial perfusion). A
coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.
E.1425 Programmable diagnostic
computer2 A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters
based on the output from one or more electrodes, transducers, or measuring de vices; this device includes any associated
commercially supplied programs.
E.1435 Single-function
preprogrammed diagnostic
computer2 A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-
flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.
E.1450 Densitometer 2 A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.
E.1650 Angiographic injector and
syringe2 An angiographic injector and syringe is a device that consists of a syringe and a high- pressure injector which are used to inject
contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
E.1660 Indicator injector 2 An indicator injector is an electrically or gas- powered device designed to inject accurately an indicator solution into the blood
stream. This device may be used in conjunction with a densitometer or thermodilution device to determine cardiac output.
E.1670 Syringe actuator for an
injector2 A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or ind icator
injector and synchronizes the injection with the electrocardiograph signal.
E.1750 External programmable
pacemaker pulse generator2 An external programmable pacemaker pulse generator is a device that can be programmed to produce one or more pulses at
preselected intervals; this device is used in electrophysiological studies.
E.1800 Withdrawal-infusion pump 2 A withdrawal- infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samplesfor use in determining cardiac output.
E.1875 Stethoscope 1,2 (a)Manual stethoscope -- (1)Identification: A manual stethoscope is a mechanical device used to project the sounds associated with
the heart, arteries, and veins and other internal organs.(2)Classification: Class 1.
(b)Electronic stethoscope -- (1)Identification: An electronic stethoscope is an electrically amplified device used to project the
sounds associated with the heart, arteries, and veins and other internal organs. (2)Classification: Class 2.
E.1915 Thermodilution probe 2 A ther modilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly
attached to a catheter that may have one or more probes.
E.2050 Biopotential amplifier and
signal conditioner2 A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.
E.2060 Transducer signal amplifier
and signal conditioner2 A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify
or condition the signal emitted by the transducer.
E.2100 Cardiovascular blood
flowmeter2 A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and proce sses
and displays the blood flow signal.
E.2120 Extravascular blood flow
probe2 An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood
flowmeter to measure blood flow in a chamber or vessel.
E.2300 Cardiac monitor (including
cardiotachometer and rate
alarm)2 A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signa l
produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart
rate falls outside preset upper and lower limits.
E.2310 Apex cardiograph
(vibrocardiograph)2 An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the sig nal from an apex cardiographic transducer
and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the t ransducer.
E.2320 Ballistocardiograph 2 A ballistocardiograph is a device, including a s upporting structure on which the patient is placed, that moves in response to blood
ejection from the heart. The device often provides a visual display.
E.2330 Echocardiograph 2 An echocardiograph is a device that uses ultrasonic energy to create images o f cardiovascular structures. It includes phased arrays
and two-dimensional scanners.
E.2340 Electrocardiograph 2 An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph
electrodes and to produce a visual display of the electrical signal produced by the heart.
E.2350 Electrocardiograph lead
switching adaptor2 An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads m ay
be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to crea te
standard lead combinations such as leads I, II, and III.
E.2360 Electrocardiograph 2 An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electricalelectrode signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
E.2390 Phonocardiograph 1 A phonocardiograph is a device u sed to amplify or condition the signal from a heart sound transducer. This device furnishes the
excitation energy for the transducer and provides a visual or audible display of the heart sounds.
E.2400 Vectrocardiograph 2 A vectorcardiograph is a device u sed to process the electrical signal transmitted through electrocardiograph electrodes and to
produce a visual display of the magnitude and direction of the electrical signal produced by the heart.
E.2450 Medical cathode-ray tube
display2 A medical cathode- ray tube display is a device designed primarily to display selected biological signals. This device often
incorporates special display features unique to a specific biological signal.
E.2675 Oscillometer 2 An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.
E.2700 Oximeter 2 An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen
saturation based on the amount of re flected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter
catheter.
E.2710 Ear oximeter 2 An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amou nt
of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.
E.2750 Impedance phlebograph 2 An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measurin g electrical
impedance changes in a region of the body.
E.2770 Medical Impedance
plethysmograph2 A medical impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance
changes in a region of the body such as the arms and legs for medical purposes.
E.2780 Hydraulic, pneumatic, or
photoelectric
plethysmographs2 A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using
hydraulic, pneumatic, or photoelectric measurement techniques.
E.2800 Medical magnetic tape
recorder2 A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers ,
signal conditioners, or computers.
E.2840 Apex cardiograph
transducer2 An apex cardiographic transducer is a device used to detect motion of the heart (acceleration, velocity, or displacement) by changes
in the mechanical or electrical properties of the device.
E.2850 Extravascular blood
pressure transducer2 An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electri cal
properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an ana log or digital
electrical signal related to the electrical or mechanical changes produced in the transducer.
E.2855 Implantable Intra-aneurysm
Pressure Measurement
System2 Implantable intra-aneurysm pressure measurement system is a device used to measure the intra- sac pressure in a vascular
aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the press ure
from the transducer.E.2860 Heart sound transducer 2 A heart sound transducer is an exte rnal transducer that exhibits a change in mechanical or electrical properties in relation to sounds
produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.
E.2870 Catheter tip pressure
transducer2 A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, i ts
mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accesso ry
equipment for processing.
E.2880 Ultrasonic transducer 2 An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunctio n with
an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two- dimensional
scanning transducers.
E.2890 Vessel occlusion transducer 2 A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partiall y
occluded vessel. This device includes motion, sound, and ultrasonic transducers.
E.2900 Patient transducer and
electrode cable (including
connector)2 A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals f rom, or power
or excitation signals to, patient-connected electrodes or transducers.
E.2910 Radiofrequency
physiological signal
transmitter and receiver2 A radiofrequency physiological signal transmitter and receiver is a device used to condition a physi ological signal so that it can be
transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned
by the device into its original format so that it can be displayed.
E.2920 Telephone
electrocardiograph
transmitter and receiver2 A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be
transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into
its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.
E.3250 Vascular clip 2 A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other
than intracranial vessels.
E.3260 Vena cava clip 2 A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibitin g the
flow of thromboembolic through that vessel.
E.3300 Arterial embolization device 3 An arterial embolization device is an intravascular device used to control internal bleeding or to stop the flow of blood fro m an
artery to certain abdominal tumors (e.g., renal tumors, hepatomas) and malformed arteries. This device is not intended for internal
arteries of the brain.
E.3375 Cardiovascular intravascular
filter2 A cardiovascular intravascular filter is an implant that is placed in the inferior vena cav a for the purpose of preventing pulmonary
thromboembolism (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right
side of the heart and the pulmonary circulation.
E.3450 Vascular graft prosthesis 2 A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vesse ls,excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as
polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or colla gen,
or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including huma n
umbilical cords.
E.3460 Endovascular suturing
system2 An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft an d
the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the
endovascular suture.
E.3470 Intracardiac patch or pledget
made of polypropylene,
polyethylene terephthalate,
or polytetrafluoroethylene2 An intracardiac patch or pledget made of polypropylene, polyethylen e terephthalate, or polytetrafluoroethylene is a fabric device
placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
E.3535 Intra-aortic balloon and
control system2,3 (a) Identification: An intra- aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in
the aorta to improve cardiovascular functioning during certain life- threatening emergencies, and a control system for regulating
the inflatio n and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram,
provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
(b) Classification: (1) Class 2: The device is indicated for acute coronary syndrome, cardiac and non- cardiac surgery, or
complications of heart failure. (2) Class 3: The device is indicated for septic shock and pulsatile flow generation.
E.3545 Ventricular bypass (assist)
device3 A ventricular by pass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The
device is either totally or partially implanted in the body.
E.3600 External pacemaker pulse
generator3 An external pacemaker pulse gener ator is a device that has a power supply and electronic circuits that produce a periodic electrical
pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic
pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac
surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R- wave sensitivity, and other
pacing variables.
E.3610 Implantable pacemaker
pulse generator3 An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic
electrical pulse to stimulate the heart. This device is used as a substitute for the he art's intrinsic pacing system to correct both
intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices
implanted in the human body.
E.3620 Pacemaker lead adaptor 2 A pacemaker lead adaptor i s a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator
produced by a different manufacturer.
E.3630 Pacemaker generator 2 A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of thefunction analyzer generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
E.3650 Pacemaker polymeric mesh
bag1 A pacemaker polymeric mesh bag is an implanted device use d to hold a pacemaker pulse generator. The bag is designed to create
a stable implant environment for the pulse generator.
E.3670 Pacemaker charger 1 A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.
E.3680 Cardiovascular permanent
or temporary pacemaker
electrode2,3 (a)Temporary pacemaker electrode --(1) Identification: A temporary pacemaker electrode is a device consisting of flexible
insulated electrical conductors with one end connected to an ex ternal pacemaker pulse generator and the other end applied to
the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transm it
the electrical signal of the heart to the pulse generator. (2) Classification: Class 2.
(b)Permanent pacemaker electrode --(1) Identification: A permanent pacemaker electrode is a device consisting of flexible
insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other e nd applied
to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to tra nsmit
the electrical signal of the heart to the pulse generator. (2) Classification: Class 3.
E.3690 Pacemaker test magnet 1 A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inh ibited
or triggered generator to revert to asynchronous operation.
E.3700 Pacemaker programmers 3 A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a
pacemaker.
E.3710 Pacemaker repair or
replacement material3 A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a
pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.
E.3720 Pacemaker electrode
function tester2 A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lea d that supplies an accurately
calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.
E.3730 Pacemaker service tools 1 Pacemaker service tools are devices such as screwdrivers and Allen wrenches, u sed to repair a pacemaker lead or to reconnect a
pacemaker lead to a pacemaker generator.
E.3800 Annuloplasty ring 2 An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive trea tment of
valvular insufficiency.
E.3850 Carotid sinus nerve
stimulator3 A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the
carotid sinus.
E.3925 Replacement heart valve 3 A replacement he art valve is a device intended to perform the function of any of the heart's natural valves. This device includes
valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of
prosthetic and biologic materials.
E.3935 Prosthetic heart valve holder 1 A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.E.3945 Prosthetic heart valve sizer 1 A prosthetic heart valve sizer is a d evice used to measure the size of the natural valve opening to determine the size of the
appropriate replacement heart valve.
E.4075 Endomyocardial biopsy
device2 An endomyocardial biopsy device is a device used in a catheterization procedure to remove s amples of tissue from the inner wall
of the heart.
E.4100 Extracorporeal circuit and
accessories for long-term
respiratory/cardiopulmonary
failure2 An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (> 6 hours) is a system of devices
and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in pati ents
with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued
clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are
not limited to, the console (hardware), software, and disposables, including, but not limited to , an oxygenator, blood pump, heat
exchanger, cannula, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors, etc.).
E.4200 Cardiopulmonary bypass
accessory equipment1,2 Cardiopulmonary bypass accessory equipment is a devi ce that has no contact with blood and that is used in the cardiopulmonary
bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator
mounting bracket or system-priming equipment. Classification:(1) Class 1 devices do not involve an electrical connection to the
patient. ;(2) Class 2 devices involve an electrical connection to the patient.
E.4205 Cardiopulmonary bypass
bubble detector2 A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary
bypass circuit.
E.4210 Cardiopulmonary bypass
vascular catheter, cannula,
or tubing2 A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmon ary surgery to cannulate the
vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device include s
accessory bypass equipment.
E.4220 Cardiopulmonary bypass
heart-lung machine console2 A cardiopulmonary bypass heart- lung machine console is a device that consists of a control panel and the electrical power and
control circuitry for a heart- lung machine. The console is designed to interface with the basic units used in a gas exchange system,
including the pumps, oxygenator, and heat exchanger.
E.4230 Cardiopulmonary bypass
defoamer2 A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery
to remove gas bubbles from the blood.
E.4240 Cardiopulmonary bypass
heat exchanger2 A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to
warm or cool the blood or perfusion fluid flowing through the device.
E.4250 Cardiopulmonary bypass
temperature controller2 A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a
heat exchanger.
E.4260 Cardiopulmonary bypass
arterial line blood filter2 A cardiopulmona ry bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter
nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct
circulation by blocking a vessel) out of the blood. It is used in the arterial return line.E.4270 Cardiopulmonary bypass
cardiotomy suction line
blood filter2 A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to
filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will ob struct
circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
E.4280 Cardiopulmonary prebypass
filter2 A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris
from the circuit prior to initiating bypass. The device is not used to filter blood.
E.4290 Cardiopulmonary bypass
adaptor, stopcock, manifold,
or fitting2 A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and
therapeutic applications to interconnect tubing, catheters, or other devices.
E.4300 Cardiopulmonary bypass
gas control unit2 A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The de vice
is calibrated for a specific gas.
E.4310 Cardiopulmonary bypass
coronary pressure gauge2 A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure
of the blood perfusing the coronary arteries.
E.4320 Cardiopulmonary bypass
pulsatile flow generator3 A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsati le
blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.
E.4330 Cardiopulmonary bypass
on-line blood gas monitor2 A cardiopulmonary bypass on- line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level
of gases in the blood.
E.4340 Cardiopulmonary bypass
level sensing monitor and/or
control2 A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood i n the
blood reservoir and to sound an alarm when the level falls below a predetermined value.
E.4350 Cardiopulmonary bypass
oxygenator2 A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the
gas exchange needs of a patient during open-heart surgery.
E.4360 Nonroller-type
cardiopulmonary bypass
blood pump3 A nonroller- type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood
through the cardiopulmonary bypass circuit during bypass surgery.
E.4370 Roller-type
cardiopulmonary bypass
blood pump2 A roller- type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through
the cardiopulmonary bypass circuit during bypass surgery.
E.4380 Cardiopulmonary bypass
pump speed control2 A cardiopulmonary b ypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or
both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.
E.4390 Cardiopulmonary bypass 2 A cardiop ulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclicallypump tubing compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
E.4400 Cardiopulmonary bypass
blood reservoir2 A cardiopulmonary bypass blood reservoir is a device used in conjunction with short- term extracorporeal circulation devices to
hold a reserve supply of blood in the bypass circulation.
E.4410 Cardiopulmonary bypass in-
line blood gas sensor2 A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.
E.4420 Cardiopulmonary bypass
cardiotomy return sucker2 A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, an d a probe or tip that is used
to remove blood from the chest or heart during cardiopulmonary bypass surgery.
E.4430 Cardiopulmonary bypass
intracardiac suction control2 A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return
sucker.
E.4450 Vascular clamp 2 A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
E.4475 Surgical vessel dilator 2 A surgical vessel dilator is a device used to enlarge or calibrate a vessel.
E.4500 Cardiovascular surgical
instruments1 Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. Th ese
devices include, e.g., forceps, retractors, and scissors.
E.4510 Apical closure device 2 An apical closure device is a device consisting of a delivery system and implant component that is used for soft tissue
approximation of cardiac apical tissue during transcatheter valve replacement procedures.
E.4875 Intraluminal artery stripper 2 An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterio sclerotic
arteries.)
E.4885 External vein stripper 2 An external vein stripper is an extravascular device used to remove a section of a vein.
E.5050 Patient care suction
apparatus2 A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery
period following surgery.
E.5150 Embolectomy catheter 2 An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboembolic , i.e., blood clots which have migrated
in blood vessels from one site in the vascular tree to another.
E.5175 Septostomy catheter 2 A septostomy catheter is a speci al balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of
certain infants.
E.5200 External cardiac compressor 3 An external cardiac compressor is an external device that is electrically, pneumatically, or manuall y powered and is used to
compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest.
E.5210 CPR aid 1, 2 (a)A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/o r simple
prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback
related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR
to assure proper use and the delivery of optimal CPR to the victim. Classification: Class 1.(b)A CPR Aid device with feedback is a device that provides real- time feedback to the rescuer regarding the quality of CPR
being delivered to the victim, and provid es either audio and/or visual information to encourage the rescuer to continue the
consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be
limited to, parameters such as compression rate, co mpression depth, ventilation, recoil, instruction for one or multiple rescuers,
etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform
effective CPR on a victim. Classification: Class 2.
E.5225 External counter-pulsating
device2,3 (a)Identification: An external counter- pulsating device is a noninvasive device used to assist the heart by applying positive or
negative pressure to one or more of the body's limbs in synchrony with the heart cycle.
(b)Classification: (1) Class 2: The device is for the treatment of chronic stable angina. (2) Class 3: Those that do not fit the
description listed in Class 2.
E.5300 DC-defibrillator(including
paddles)2,3 (a)Low-energy DC-defibrillator (1)Identification: A low-energy DC- defibrillator is a device that delivers into a 50 ohm test load
an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or
ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators
with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac su rgery.
The device may either synchronize the shock wit h the proper phase of the electrocardiogram or may operate asynchronously.
The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.
(2)Classification: Class 2.
(b)High-energy DC-defibrillator (1)Identification: A high-energy DC- defibrillator is a device that delivers into a 50 ohm test load
an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to t erminate
other cardiac arr hythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or
may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart
or on the surface of the body. (2)Classification: Class 3.
E.5310 Automated external
defibrillator system3 An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and
interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric
use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an
electrical shock (fully automated AED), or advises the user to deliver the shock (semi- automated or shock advisory AED) to treat
ventricular fibrillation or pulseless ventricular tachycardia.
E.5325 Defibrillator tester 2 A defibrillator tester is a device that is connected to the output of a defibril lator and is used to measure the energy delivered by the
defibrillator into a standard resistive load. Some testers also provide waveform information.
E.5550 External transcutaneous
cardiac2 An external transcutaneous cardiac pacem aker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace
the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.pacemaker(noninvasive)
E.5700 Steerable cardiac ablation
catheter remote control
system2 A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the m anual
handle of a steerable cardiac ablation catheter to remotely control the advancement, ret raction, rotation, and deflection of a
compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The dev ice allows
reversion to manual control of the steerable cardiac ablation catheter without wi thdrawal of the catheter and interruption of the
procedure.
E.5800 Compressible limb sleeve 2 A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around
the limb.
E.5900 Thermal regulating system 2 A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a tem perature
controller for the device. The system is used to regulate patient temperature.
E.5910 Esophageal thermal
regulation device2 An esophageal thermal regulation device is a device used to apply a specified temperature to the endoluminal surface of the
esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suc tioning. The
device is used to regulate patient temperature.
E.5925 Automatic rotating
tourniquet2 An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the to tal
blood volume, thereby reducing the normal workload of the heart.
E.9999 Others(Cardiovascular
Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
F.0001 Retraction cord 1,2 Retraction cord inserted in gums (gingiva) is used to extend the space between teeth and gums. Classification:(1) Retraction cord
contains medicine is class 2. (2) Others are class 1.
F.0002 Orthodontic planning
software2 Orthodontic Planning Software is a software that is to be used for the diagnosis and treatment planning of orthodontic patients
F.1500 Gingival fluid measurer 1 A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between
the tooth and gums) to determine if there is a gingivitis condition.
F.1720 Pulp tester 2 A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequenc y
current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.
F.1730 Electrode gel for pulp tester 1 An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid
conduction of electrical current.
F.1740 Caries detection device 2 The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.
F.1745 Laser fluorescence caries
detection device2 A laser fluorescence caries detection dev ice is a laser, a fluorescence detector housed in a dental handpiece, and a control console
that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use ofthe device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.
F.1800 Extraoral source x-ray
system2 An extraoral source x-ray system is an AC-powered device that produces x- rays and is intended for dental radiographic
examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x- ray source (a tube) is located outside the mouth.
This generic type of device may include patient and equipment supports and component parts.
F.1810 Intraoral source x-ray
system2 An intraoral source x-ray system is an electrically powered device that produces x- rays and is intended for dental radiographic
examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x- ray source (a tube) is located inside the mouth.
This generic type of device may include patient and equipment supports and component parts.
F.1820 Dental x-ray exposure
alignment device1 A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x-
ray beam.
F.1830 Cephalometer 2 A cephalometer is a device used in dentistry during x- ray procedures. The device is intended to place and to hold a patient's head
in a standard position during dental x-rays.
F.1840 Dental x-ray position
indicating device1 A dental x- ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic
examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of t he dental
x-ray field by limiting the size of the primary x-ray beam.
F.1850 Lead-lined position
indicator1 A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x- ray tube and intended to aid in
positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.
F.1870 Sulfide detection device 2 A sulfide detection device is a device consisting of an AC-powered control unit, probe handle, pro be tips, cables, and accessories.
This device is intended to be used in vivo, to manually measure periodontal pocket probing depths, detect the presence or abs ence
of bleeding on probing, and detect the presence of sulfides in periodontal pockets, as an ad junct in the diagnosis of periodontal
diseases in adult patients.
F.2050 Dental sonography device 1,2 (1)Dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular
joint sounds. The device detects and records sounds made by the temporomandibular joint. Classification: Class 1. (2 )Dental
sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular
joint sounds for the diagnosis o f temporomandibular joint disorders and associated orofacial pain. The device detects, records,
displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to
generate meaningful output, either di rectly or by connection to a personal computer. The device may be part of a system of devices,
contributing joint sound information to be considered with data from other diagnostic components. Classification: Class 2.F.2060 Jaw tracking device 1,2 (a)Jaw tracking device for monitoring mandibular jaw positions relative to the maxilla (1)Identification: A jaw tracking device for
monitoring mandibular jaw positions relative to the maxilla is a nonpowered or electrically powered device that measures and
records anatomical distances and angles in three dimensional space, to determine the relative position of the mandible with respec t
to the location and position of the maxilla, while at rest and during jaw movement.(2)Classification: Class 1.(b)Jaw tracking dev ice
for interpretation of mandibular jaw positions for the diagnosis (1)Identification. A jaw tracking device for interpretation of
mandibular jaw positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofa cial
pain is a nonpowered or electrically powered device that measures and records anatomical distances and angles to determine th e
relative position of the mandible in three-dimensional space, with respect to the location and position of the maxilla, whil e at rest
and during jaw movement. The device records, displays, and stores information about jaw position. The device interprets jaw
position to generate meaningful output, either directly or by connection to a personal computer. The device may be a part of a
system of devices, contributing jaw position information to be considered with data from other diagnostic components. (2)
Classification: Class 2.
F.3060 Gold based alloys and
precious metal alloys for
clinical use2 A noble metal alloy is a device c omposed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended
for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
F.3070 Dental amalgam, mercury,
and amalgam alloy2 Dental amal gam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed
capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predo sed
capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual
component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.
F.3080 Mercury and alloy dispenser 1 A mercury and alloy dispenser is a device with a spring- activated valve intended to measure and dispense into a mixing capsule a
predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.
F.3100 Dental amalgamator 1 A dental amalgamator is a device, usually AC- powered, intended to mix, by shaking, amalgam capsules containing mercury and
dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.
F.3110 Dental amalgam capsule 1 A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.
F.3130 Preformed anchor 1 A preformed anchor is a device made of austen itic alloys or alloys containing 75 percent or greater gold or metals of the platinum
group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.
F.3140 Resin applicator 1 A resin applicator is a brush like device intended for use in spreading dental resin on a tooth during application of tooth shade
material.
F.3165 Precision attachment 1 A precision attachment or preformed bar is a device made of austenitic alloys or alloys contai ning 75 percent or greater gold and
metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various formsof the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture
with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed
bridge to a partial denture.
F.3200 Resin tooth bonding agent 2 A resin tooth bonding agent is a device material, such as methyl methacrylate, intended to be painted on the interior of a prepared
cavity of a tooth to improve retention of a restoration, such as a filling.
F.3220 Facebow 1 A facebow is a device intended for use in denture fabrication to determine the spatial relationship between the upper and lower
jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding corre ct
placement of artificial teeth into a denture base.
F.3240 Dental bur 1 A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mou th,
such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the
fabrication of dental devices.
F.3250 Calcium hydroxide cavity
liner2 A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before inse rtion of
restorative material, e.g., amalgam etc., to protect the pulp of a tooth.
F.3260 Cavity varnish 2 Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of rest orative
materials. The device is intended to prevent penetration of restorative materials, e.g., amalgam etc., into the dentinal tissue.
F.3275 Dental cement 1,2 Dental cement is a device intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filli ng, to
affix den tal devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. This device is made by zinc
oxide-eugenol. Classification: (1)Class 1: The main component is Zinc oxide-eugenol ;(2)Class 2: The main component is Dental
cement other than zinc oxide-eugenol.
F.3285 Preformed clasp 1 A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 perce nt or
greater gold and metals of the platinum group intended to be incorpor ated into a dental appliance, such as a partial denture, to help
stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.
F.3300 Hydrophilic resin coating
for dentures2 A hydrophilic resin coating for dentures is a device that consists of a water- retaining polymer that is intended to be applied to the
base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.
F.3310 Coating material for resin
fillings2 A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to at tain a
smooth, glaze-like finish on the surface of the filling.
F.3330 Preformed crown 1 A preformed crown is a prefabricated devi ce made of plastic or austenitic alloys or alloys containing 75 percent or greater gold
and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown
(that portion of the tooth that norma lly protrudes above the gums). It is intended for use as a functional restoration until a permanent
crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby )
tooth until the adult tooth erupts.F.3350 Gold or stainless steel cusp 1 A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and
metals of the platinum group or stainless steel intended to provide a perma nent cusp (a projection on the chewing surface of a
tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable denture.
F.3360 Preformed cusp 1 A performed cusp is a prefabricated device made of plastic or austenitic alloys or al loys containing 75 percent or greater gold and
metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achi eve
occlusal harmony (a proper bite) before permanent restoration of a tooth.
F.3400 Karaya and sodium borate
with or without acacia
denture adhesive1,3 A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or
without acacia intended to be applied to the base of a dentur e before the denture is inserted into patient's mouth to improve denture
retention and comfort.(1)Classification: Class 1 the device contains less than 12 percent by weight of sodium borate ;(2)Class 3
the device contains 12 percent or more by weight of sodium borate.
F.3410 Ethylene oxide
homopolymer and/or
carboxymethyl-cellulose
sodium denture adhesive1 An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing ethylene oxide
homopolymer and/or carboxymet hylcellulose sodium intended to be applied to the base of a denture before the denture is inserted
in a patient's mouth to improve denture retention and comfort.
F.3420 Carboxymethylcellulose
sodium and cationic
polyacrylamide polymer
denture adhesive3 Acarboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive is a device composed of
carboxymethylcellulose sodium and cationic polyacrylamide polymer intended to be applied to the base of a denture before the
denture is inserted in a patient's mouth to improve denture retention and comfort.
F.3450 Ethylene oxide
homopolymer and/or karaya
denture adhesive1 Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya
intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention a nd
comfort.
F.3480 Polyacrylamide polymer
(modified cationic) denture
adhesive3 A polyacrylamide polymer (modified cationic) dent ure adhesive is a device composed of polyacrylamide polymer (modified
cationic) intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve dent ure
retention and comfort.
F.3490 Carboxymethylcellulose
sodium and/or
polyvinylmethylether maleic
acid calcium-sodium double
salt denture adhesive1 A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium- sodium double salt denture adhesive is a
device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium- sodium double salt
intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retent ion and
comfort.
F.3500 Polyvinylmethylether
maleic anhydride (PVM-3 Polyvinylmethylether maleic anhydride (PVM- MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture
adhesive is a device composed of polyvinylmethyleth er maleic anhydride, acid copolymer, and carboxymethylcellulose sodiumMA), acid copolymer, and
carboxymethylcellulose
sodium (NACMC) denture
adhesive)intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retent ion and
comfort.
F.3520 OTC dental appliance
cleanser1 An OTC dental appliance cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intende d to
remove debris from removable prosthetic dental appliances, such as bridges , dentures, braces, and retainers. The dental appli ance
is removed from the patient's mouth when the appliance is cleaned.
F.3540 OTC denture cushion or pad 1,2 An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a
loose or uncomfortable denture, and may be available for purchase over-the-counter. Classification: (1)Class 1 the device is made
of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into
the mouth. (2)Class 2 if the OTC denture cushion or pad is made of a material other than wax- impregnated cotton cloth or if the
intended use of the device differs from that described in paragraph (1).
F.3560 OTC denture reliner 2 An OTC denture reliner is a device co nsisting of a material such as plastic resin that is intended to be applied as a permanent
coating or lining on the base or tissue- contacting surface of a denture. The device is intended to replace a worn denture lining and
may be available for purchase over the counter.
F.3570 OTC denture repair kit 2 An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, th at is
intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over- the
counter.
F.3580 Preformed gold denture
tooth1 A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals
of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.
F.3590 Preformed plastic denture
tooth2 A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intende d
for use as a tooth in a denture.
F.3600 Partially fabricated denture
kit2 A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in construction of a
denture. A denture base is constructed using th e patient's mouth as a mold, by partially polymerizing the resin denture base
materials while the materials are in contact with the oral tissues. After the denture base is constructed, the connected pref ormed
teeth are chemically bonded to the base.
F.3630 Endosseous dental implant
abutment2 An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental
implant and is intended for use as an aid in prosthetic rehabilitation.
F.3640 Endosseous implant 3 An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that is intended to be surgic ally
placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teet h, in order to
restore a patient's chewing function.F.3645 Subperiosteal implant
material2 Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom
prosthetic devices which are surgically i mplanted into the lower or upper jaw between the periosteum (connective tissue covering
the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.
F.3660 Impression material 2 Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed
impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models f or
study and for production of restorative prosthetic devices, such as gold inlays and dentures.
F.3661 Optical Impression Systems
for CAD/CAM1 An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the
topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-
assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or
equivalent type of sensor and a computer with software.
F.3670 Resin impression tray
material1 Resin impression tray material is a device intended for use in a two- step dental mold fabricating process. The device consists of a
resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed
impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of
the patient's teeth and gums is made. The resin impression tray material is applied to this preliminary study model to form a custom
tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from whi ch a
final, more precise, model of the patient's mouth is cast.
F.3680 Polytetrafluoroethylene
(PTFE) vitreous carbon
material2 Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbo n
intended for use in maxillofacial alveo lar ridge augmentation (building up the upper or lower jaw area that contains the sockets in
which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth a re rooted)
or the temporomandibular joints (the joint between the upper and lower jaws).
F.3690 Tooth shade resin material 2 Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis- GMA) intended to
restore carious lesions or structural defects in teeth.
F.3710 Base metal alloy 2 A base metal alloy is a device composed primarily of base metals, e.g., nickel, chromium, or cobalt, etc. , that is intended for use
in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
F.3740 Retentive and splinting pin 1 A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metal s of the
platinum group intended to be placed permanently in a tooth to provide retention and s tabilization for a restoration, such as a
crown, or to join two or more teeth together.
F.3750 Bracket adhesive resin and
tooth conditioner2 A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, e.g., polymethylmethacrylate, etc. ,
intended to cement an orthodontic bracket to a tooth surface.
F.3760 Denture relining, repairing,
or rebasing resin2 A denture relining, repairing, or rebasing resin is a device composed of materials such as methyl methacrylate, intended to reline
a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not avai lable forover-the-counter (OTC) use.
F.3765 Pit and fissure sealant and
conditioner2 A pit and fissure sealant and con ditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily
in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.
F.3770 Temporary crown and
bridge resin2 A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a
temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
F.3810 Root canal post 1 A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the pla tinum
group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
F.3820 Root canal filling resin 2,3 A root canal filling resin is a device composed of material, such as methyl methacrylate, intended for use during endodontic therapy
to fill the root canal of a tooth. Classification: (1) Class 2 if chloroform is not used as an ingre dient in the device. (2) Class 3 if
chloroform is used as an ingredient in the device.
F.3830 Endodontic paper point 1 An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to ,
the root canal of a tooth.
F.3840 Endodontic silver point 1 An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal
of a tooth.
F.3850 Gutta percha 1 Gutta percha is a device made from co agulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta
percha is softened by heat and inserted into the root canal, where it hardens as it cools.
F.3890 Endodontic stabilizing splint 2 An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal
into the upper or lower jaw bone to stabilize a tooth.
F.3900 Posterior artificial tooth
with a metal insert1 A posterior artificial tooth with a metal inse rt is a porcelain device with an insert made of austenitic alloys or alloys containing 75
percent or greater gold and metals of the platinum group intended to replace a natural tooth. The device is attached to surro unding
teeth by a bridge and is intended to provide both an improvement in appearance and functional occlusion (bite).
F.3910 Backing and facing for an
artificial tooth1 A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appli ance,
such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth- colored
facing, which is made of porcelain or plastic.
F.3920 Porcelain tooth 2 A porcelain tooth is a prefabricated device mad e of porcelain powder for clinical use (F.6660) intended for use in construction of
fixed or removable prostheses, such as crowns and partial dentures.
F.3930 Tricalcium phosphate
granules for dental bone
repair2,3 Bone grafting material is a material su ch as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen
that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Classification: (1)
Class 2 devices do not contain medicine. (2) Class 3 devices contain medicine.
F.3940 Total temporomandibular 3 A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandi bularjoint prosthesis condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
F.3950 Glenoid fossa prosthesis 3 A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid f ossa
or to provide an articulation surface for the head of a mandibular condyle.
F.3960 Mandibular condyle
prosthesis3 A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condy le
and to articulate within a glenoid fossa.
F.3970 Interarticular disc prosthesis
(interpositional implant)3 An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natur al
articulating surface of the mandibular condyle and glenoid fossa.
F.3980 Endosseous dental implant
accessories1 Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous
dental implants and abutments, prepare the site for placement of end osseous dental implants or abutments, aid in the fitting of
endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endos seous
dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, counter torque devices,
placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.
F.4120 Bone cutting instrument and
accessories2 A bone cutting instrume nt and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the
upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and
wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
F.4130 Intraoral dental drill 1 An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or
preformed pins to retain operative dental appliances.
F.4200 Dental handpiece and
accessories1 A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand- held device that may
include a foot controller for regulation of speed and direction of rotation or a contra- angle attachment for difficult to reach areas
intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
F.4465 Gas-powered jet injector 2 A gas-powered jet injector is a syringe devi ce intended to administer a local anesthetic. The syringe is powered by a cartridge
containing pressurized carbon dioxide which provides the pressure to force the anesthetic out of the syringe.
F.4475 Spring-powered jet injector 2 A spring-powered jet inj ector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring
mechanism which provides the pressure to force the anesthetic out of the syringe.
F.4535 Dental diamond instrument 1 A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The
device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation o f the
diamond instrument provides an abrasive action when it contacts a tooth.
F.4565 Dental hand instrument 1 A dental hand instrument is a hand- held device intended to perform various tasks in general dentistry and oral surgery procedures.
The device includes the operative burnisher, oper ative amalgam carrier, operative dental amalgam carver, surgical bone chisel,
operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental su rgicalelevator, operative dental excavator, operativ e explorer surgical bone file, operative margin finishing file, periodontic file,
periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix
contouring instrument, operative cutting i nstrument, operative margin finishing periodontic knife, periodontic marker, operative
pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, c rown
remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel,
endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge
instrument, plastic dental filling instr ument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band
driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligatu re
tucking instrument, forceps, for artic ulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor,
dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.
F.4600 Intraoral ligature and wire
lock2 An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The b one
segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.
F.4620 Fiber optic dental light 1 A fiber optic dental light is a device that is a light, usually AC- powered, that consists of glass or plastic fibers which have special
optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures.
F.4630 Dental operating light 1 A dental operating light, including the surgical headlight, is an AC- powered device intended to illuminate oral structures and
operating areas.
F.4730 Dental injecting needle 1 A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local
anesthetics and other drugs.
F.4760 Bone plate 2 A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to
the plate with screws to prevent movement of the segments.
F.4770 Temporary mandibular
condyle reconstruction plate2 A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for
temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone
respective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for
treatment of temporomandibular joint disorders.
F.4840 Rotary scaler 2 A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth d uring
dental cleaning and periodontal (gum) therapy.
F.4850 Ultrasonic scaler 2 An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus dep osits
from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
F.4880 Intraosseous fixation screw
or wire2 An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their
movement.
F.4920 Dental electrosurgical unit 2 A dental electrosurgical unit and accessories is an AC- powered device consisting of a controlled power source and a set of cuttingand accessories and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during s urgical procedures
in the oral cavity. Depending on the mode of operational selection, it cuts through soft tissue or coagulates the tissue after an
electrical current passes through the tip of the electrode into the tissue..
F.5410 Orthodontic appliance and
accessories1 An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a to oth so
that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodonti c band material,
orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodon tic
expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
F.5470 Orthodontic plastic bracket
and aligner2 (a)An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexi ble
orthodontic wire to alter its position.
(b)Orthodontic aligners are devices that treat teeth with minor malocclusions and can gently move the position of the teeth. The
thermoplastic resin device, with patient scanning software or/and hardware, is to design and create a series of plastic
orthodontic appliances and to gradually move the teeth by using the patient's dental digital scan file.
F.5500 Extraoral orthodontic
headgear2 An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth f rom
outside the mouth. The headgear has a strap intende d to wrap around the patient's neck or head and an inner bow portion intended
to be fastened to the orthodontic appliance in the patient's mouth.
F.5525 Preformed tooth positioner 1 A preformed tooth positioner is a plastic device that is made for an impr ession of a bite intended to prevent a patient's teeth from
shifting position or to maintain teeth in a final position after orthodontic appliances (braces) have been removed. The patie nt bites
down on the device for several hours a day to stabilize the position of the teeth.
F.5560 Electrical salivary
stimulatory system2 An electrical salivary stimulatory system is an intraoral device that is intended to electrically stimulate a relative increase in saliva
production.
F.5570 Intraoral devices for snoring
and intraoral devices for
snoring and obstructive
sleep apnea2 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep
to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the
airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue ret aining
devices, and mandibular repositioning devices.
F.6010 Abrasive device and
accessories1 An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-
based paper. The device is intended to remove excessive restorative materials, such as gold , and to smooth rough surfaces from
oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abr asive
disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.
F.6030 Oral cavity abrasive
polishing agent1 An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silic a pumice,
intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).
F.6050 Saliva absorber 1 A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.F.6070 Ultraviolet activator for
polymerization2 An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resi nous
dental pit and fissure sealants or restorative materials by transmission of light through a rod.
F.6080 Airbrush 2 An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air- driven particles
to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.
F.6100 Anesthetic warmer 1 An anesthetic warmer is an AC- powered device into which tubes containing anesthetic solution are intended to be placed to warm
them prior to administration of the anesthetic.
F.6140 Articulation paper 1 Articulation pape r is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and
lower teeth when the teeth are in the bite position to locate uneven or high areas.
F.6200 Base plate shellac 1 Base plant shellac is a device composed of shellac intended to rebuild the occlusal rim of full or partial dentures.
F.6250 Dental chair and accessories 1 A dental chair and accessories is a device, usually AC- powered, in which a patient sits. The device is intended to properly position
a patient to perform dental procedures. A dental operative unit may be attached.
F.6290 Prophylaxis cup 1 A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents dur ing
prophylaxis (cleaning ). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth
to remove debris.
F.6300 Rubber dam and accessories 1 A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in t he center intended to isolate a tooth
from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a too th by
inserting a tooth through a hole in the center. The device includes the rubber dam, rub ber dam clamp, rubber dam frame, and
forceps for a rubber dam clamp.
F.6350 Ultraviolet detector 2 An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise inv isible
material, such as dental plaque, present in or on teeth.
F.6475 Heat source for bleaching
teeth1 A heat source for bleaching teeth is a device that consists of a light or an electric heater intended to apply heat to a tooth after it is
treated with a bleaching agent.
F.6570 Impression tube 1 An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollo w
tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, th e remaining end is
slipped over the tooth to make the impression.
F.6640 Dental operative unit and
accessories1 A dental operative unit and accessories is an AC- powered device that is intended to supply power to and serve as a base for other
dental devic es, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction
operative unit, and other dental devices and accessories. The device may be attached to a dental chair.
F.6660 Porcelain powder for
clinical use2 Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intende d for use
in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and ven eers. The device is used inprosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass- like
finish.
F.6710 Boiling water sterilizer 1 A boiling water sterilizer is an AC-powered device tha t consists of a container for boiling water. The device is intended to sterilize
dental and surgical instruments by submersion in the boiling water in the container.
F.6730 Endodontic dry heat
sterilizer3 An endodontic dry heat sterilizer is a device int ended to sterilize endodontic and other dental instruments by the application of dry
heat. The heat is supplied through glass beads which have been heated by electricity.
F.6770 Cartridge syringe 2 A cartridge syringe is a device intended to inject anesth etic agents subcutaneously or intramuscularly. The device consists of a
metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed.
After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device
is used to administer an injection to the patient.
F.6870 Disposable fluoride tray 1 A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient
bites down on the tray which has been filled with a fluoride solution.
F.6880 Preformed impression tray 1 A preformed impression tray is a metal or plastic device intended to hold impression material, s uch as alginate, to make an
impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.
F.6890 Intraoral dental wax 1 Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such
as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to ma ke study
models of the teeth.
F.9999 Others(Dental Devices) 1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
G.0001 Cochlear implant 3 A cochlear implant establishes hearing capability for a hearing impaired patient by us ing electrical signals (e.g., electrical currents,
etc.) to stimulate auditory nerve.
G.1050 Audiometer 1,2 An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals
intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Classification: (1) Class 1 ;(2) Class 2: otoacoustic emission device.
G.1070 Short increment sensitivity
index (SISI) adapter1 A short increment sensi tivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI
adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the
audiometer's output tone frequency.
G.1090 Auditory impedance tester 2 An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measu re and
graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is
used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of flu id inthe middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle,
to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the
middle ear.
G.1100 Earphone cushion for
audiometric testing1 An earpho ne cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing
to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.
G.1120 Electronic noise generator
for audiometric testing2 An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an
earphone. It is intended to introduce a masking noise into the non-test ear during an au diometric evaluation. The device minimizes
the non-test ear's sensing of test tones and signals being generated for the ear being tested.
G.1325 Electroglottograph 2 An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both
sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing
the degree of closure of the vocal cords, confirm laryngeal diagnosis, aid behav ioral treatment of voice disorders, and aid research
concerning the laryngeal mechanism.
G.1500 Gustometer 1 A gustometer is a battery- powered device that consists of two electrodes that are intended to be placed on both sides of the tongue
at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.
G.1600 Olfactory test device 1 An olfactory test device is used to determine whether an olfactory loss is present. The device inc ludes one or more odorants that
are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.
G.1800 Air or water caloric
stimulator1 An air or water caloric stimulator is a device that delivers a stream of air or wa ter to the ear canal at controlled rates of flow and
temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulati on of
the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph.
G.1820 Surgical nerve
stimulator/locator2 A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify
nerves and to test their excitability.
G.1925 Toynbee diagnostic tube 1 The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.
G.3300 Hearing aid 1,2 A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device
includes the air-conduction hearing aid and the bone- conduction hearing aid, but excludes the group hearing aid or group auditory
trainer (G.3320), master hearing aid (G.3330), and tinnitus masker (G.3400). Classification: (1) Class 1 for the air- conduction
hearing aid. (2) Class 2 for the bone-conduction hearing aid.
G.3310 Hearing aid calibrator and
analysis system2 A hearing aid calibrator and analysis system is an electronic reference device intended t o calibrate and assess the electroacoustic
frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group au ditory
trainer. The device consists of an acoustic complex of known cavity volume, a sou nd level meter, a microphone, oscillators,frequency counters, microphone amplifiers, a distortion analyzer, a chart recorder, and a hearing aid test box.
G.3315 Tympanic membrane
contact hearing aid2 A tympanic membrane contact hearing aid is a device t hat compensates for impaired hearing. Amplified sound is transmitted by
vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
G.3320 Group hearing aid or group
auditory trainer2 A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one
or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either
monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes
three types of applications: hardwire systems, inductance loop systems, and wireless systems.
G.3330 Master hearing aid 2 A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic
output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wea rable
hearing aid.
G.3400 Tinnitius masker 2 A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the
ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises
and speech.
G.3430 Middle ear mold 2 A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair o f the
tympanic membrane. The device permits an ample air-fill ed cavity to be maintained in the middle ear and promotes regeneration
of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide,
polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.
G.3450 Partial ossicular
replacement prosthesis2 A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the
ossicular chain and facilitates the con duction of sound wave from the tympanic membrane to the inner ear. The device is made of
materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fiber s
composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.
G.3495 Total ossicular replacement
prosthesis2 A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular
chain an d facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials
such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a
combination of these materials.
G.3540 Prosthesis modification
instrument for ossicular
replacement surgery1 A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct
ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block, wire crimper, wire bending
die, wire closure forceps, piston cutting jib, gelfoamTMpunch, wire cutting scissors, and ossicular finger vise.
G.3620 Ear, nose, and throat
synthetic polymer material2 Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space- occupying
substance in the reconstructive surgery of the head and neck. The device is used, for example, in augment ation rhinoplasty and in
tissue defect closures in the esophagus. The device is shaped and formed by the surge on to conform to the patient's needs. Thisgeneric type of device is made of material such as polyamide mesh or foil and porous polyethylene.
G.3695 Mandibular implant facial
prosthesis2 A mandibular implant facial prosthesis is a device that is intended to be implanted for use in the functional reconstruction of
mandibular deficits. The device is made of materials such as stainless steel, tantalum, titanium, cobalt- chromium based alloy,
polytetrafluoroethylene, silicone elastomer, polyethylene, polyurethane, or polytetrafluoroethylene with carbon fibers composite.
G.3730 Laryngeal prosthesis (Taub
design)2 A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx,
thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be
removed and replaced each day by the pa tient. During phonation, air from the lungs is directed to flow through the device and
over the esophageal mucosa to provide a sound source that is articulated as speech.
G.3760 Sacculotomy tack (Cody
tack)2 A sacculotomy tack (Cody tack) is a device tha t consists of a pointed stainless steel tack intended to be implanted to relieve the
symptoms of vertigo. The device repetitively ruptures the utricular membrane as the membrane expands under increased
endolymphatic pressure.
G.3820 Endolymphatic shunt 2 An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptom s of vertigo.
The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoi d
cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.
G.3850 Endolymphatic shunt tube
with valve2 An endolymphatic shunt tube with valve is a device that consists of a pressure-limiting valve associated w ith a tube intended to
be implanted in the inner ear to relieve symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in
endolymphatic fluid) of Meniere's disease.
G.3880 Tympanostomy tube 2 A tympanostomy tube is a device that is in tended to be implanted for ventilation or drainage of the middle ear. The device is
inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of
tympanostomy tube known as the malleous clip tube at taches to the malleous to provide middle ear ventilation. The device is made
of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.
G.3900 Nasal dilator 1 A nasal dilator is a device intended to provide temp orary relief from transient causes of breathing difficulties resulting from
structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decrea ses
airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon
which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling a ction to
open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing
the nostrils open or by gently pressing on the columella.
G.3930 Tympanostomy tube with
semipermeable membrane2 A tympanostomy tube with a semipermeable membrane i s a device intended to be implanted for ventilation or drainage of the
middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membran e
to permit a free exchange of air between the outer ear and middle ear. The tube portion of the device is made of silicone elastomer
or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.G.3950 Transcutaneous air
conduction hearing aid
system2 A transcutaneous air conduction hearing aid system is a wearable sound- amplifying device intended to compensate for impaired
hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube
system, which is placed through soft tissue between the post auricular region and the outer ear canal.
G.4100 Epistaxis balloon 1 An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure
against the sphenopalatine artery.
G.4140 Ear, nose, and throat bur 1 An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat
electric or pneumatic surgical drill for incising or removing bone in the ear , nose, or throat area. The bur consists of a carbide
cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus s urgery,
and surgery of the facial nerves.
G.4175 Nasopharyngeal catheter 1 A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilati ng the
eustachian tube. This generic type of device includes eustachian catheters.
G.4180 Eustachian tube balloon
dilation system2 A Eustachian tube balloon dilation system is a device that includes a flexible catheter attached to an inflatable balloon. Th e system
is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
G.4250 Ear, nose, and throat electric
or pneumatic surgical drill2 An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended
to drive various accessories, such as an ear, nose, and throat bur (G.4140 ), for the controlled incision or removal of bone in the
ear, nose, and throat area.
G.4350 Ear, nose, and throat
fiberoptic light source and
carrier1 An ear, nose, and throat fiberoptic light source and carrier is an AC- powered device that generates and transmits light through
glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endosco pic devices
which utilize fiberoptic light sources and carriers inclu de the bronchoscope, esophagoscope, laryngoscope, mediastinoscope,
laryngeal-bronchial telescope, and nasopharyngoscope.
G.4420 Ear, nose, and throat manual
surgical instrument1 An ear, nose, and throat manual surgical instrument is one of a variety of d evices intended for use in surgical procedures to examine
or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device in cludes
the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set;
laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mout h
gag; oral screw; salpingeal curette; tonsillectome; tonsil guil lotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing
hook; antom reforator; ethmoid curette; frontal sinus -rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal
snare; sinus irrigator; sinus trephine; ear cure tte; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous
ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein
press; wire ear loop; microrule; m irror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat
trocar.
G.4490 Argon laser for otology, 2 The argon laser device for use in otology, rhinology, and laryngology is an electro-o ptical device which produces coherent,rhinology, and laryngology electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the
purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In rhinology and laryngology, the device
is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.
G.4500 Ear, nose, and throat
microsurgical carbon
dioxide laser2 An ear, nose, and throat microsurgical carbon dioxide la ser is a device intended for the surgical excision of tissue from the ear,
nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords
and adjacent areas.
G.4680 Bronchoscope (flexible or
rigid) and accessories2 A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices wh ich
attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tr ee. It is typically used with a
fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexi ble plastic.
This generic type of device includes the rigid ventilating bronchoscope, rigid nonvent ilating bronchoscope, nonrigid bronchoscope,
laryngeal- bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette,
flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bron choscope aspirating tube, but excludes the
fiberoptic light source and carrier.
G.4710 Esophagoscope (flexible or
rigid) and accessories2 An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices
which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or
mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the
hypoph arynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is
made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw,
flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but e xcludes
the fiberoptic light source and carrier.
G.4720 Mediastinoscope and
accessories2 A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices
which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device i s
inserted transthoracicly and is used in dia gnosis of tumors and lesions and to determine whether excision of certain organs or
tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of
materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid
biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light s ource and
carrier.
G.4750 Laryngostroboscope 1 A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operate s by
focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that
amplifies acoustic signals from the glottic area may or may not contact the patient.
G.4760 Nasopharyngoscope 2 A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices(flexible or rigid) and
accessorieswhich attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used
with a fiberoptic light source and carrier to provide illumination. The device is ma de of materials such as stainless steel and flexible
plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope,
postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biops y
brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.
G.4770 Otoscope 1 An otoscope is a device intended to allow inspection of the external ear canal an d tympanic membrane under magnification. The
device provides illumination of the ear canal for observation by using an AC- or battery- powered light source and an optical
magnifying system.
G.4780 Intranasal splint 1 An intranasal splint is intended to min imize bleeding and edema and to prevent adhesions between the septum and the nasal cavity.
It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or abs orbent
material.
G.4800 Bone Particle collector 1 A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otolog ic surgery
to collect bone particles for future use.
G.5220 Ear, nose, and throat drug
administration device and
contained substance1,2 An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to
administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear
wick, manual nebulizer pump, and nasal inhaler. Classification: Class 1: The device does not contain substance (liquid or other
substance), Class 2: The device contains flushing solution, or the substance (solution, solute, powder, e tc.) is used in combination
with the device to achieve the intended purpose, and the aforementioned solution contained in the device or substance used in
combination with the device is not regulated as a medicinal substance.
G.5300 Ear, nose, and throat
examination and treatment
unit1 An ear, nose, and throat examination and treatment unit is an AC- powered device intended to support a patient during an otologic
examination while providing specialized features for examination and treatment. The unit consis ts of a patient chair and table,
drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining
instruments.
G.5350 Suction antichoke device 3 A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction,
foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient.
G.5370 Tongs antichoke device 3 A tongs antichoke device is a device that is intended to be u sed in an emergency situation to grasp and remove foreign objects that
obstruct a patient's airway to prevent asphyxiation of the patient. This generic type of device includes a plastic instrument with
serrated ends that is inserted into the airway in a bl ind manner to grasp and extract foreign objects, and a stainless steel forceps
with spoon ends that is inserted under tactile guidance to grasp and extract foreign objects from the airway.
G.5550 Powered nasal irrigator 1 A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure- controlled pulsating
stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.G.5800 External nasal splint 1 An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
G.5840 Antistammering device 1 An antistammering device is a device that electronically generates a noise when activated or when it senses the user's s peech and
that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's
involuntary hesitative or repetitive speech.
G.9999 Others(Ear, Nose, and
Throat Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
H.0002 Dialyzer reprocessing
system2 A hemodialysis dialyzer reprocessing system is intended to clean and disinfection of reusable di alyzers. The system may include
computing system for operation.
H.0003 Urological extracorporeal
shock wave therapy system3 A urological extracorporeal shock wave therapy system is a device that can treat urology- related diseases by generating shock
waves.
H.1075 Gastroenterology-urology
biopsy instrument1,2 A gastroenterology- urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for
microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument,
suction biopsy instrument, gastro- urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not
apply to biopsy instruments that have been used in other medical specialty a reas or covered by biopsy instruments of relevant
classification categories. Classification: (1) Class 2, (2) Class 1 for the biopsy forceps cover and the non-electric biopsy forceps.
H.1300 Ingestible telemetric gastro-
intestinal capsule imaging
system2 A single-use ingestible capsule is designed to acquire video images during natural propulsion through the digestive system. It is
specifically designed to visualize the colon for the detection of polyps. It is intended for patients who are unable to perfo rm a
complete colonoscopy even with adequate preparation and for patients who are technically unable to perform a complete
colonoscopic evaluation.
H.1330 Colon Capsule Imaging
System2 A single-use ingestible capsule designed to acquire video images dur ing natural propulsion through the digestive system. It is
specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete
optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.
H.1400 Stomach pH electrode 1 A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH
electrode is at the end of a flexible lead whi ch may be inserted into the esophagus or stomach through the patient's mouth. The
device may include an integral gastrointestinal tube.
H.1500 Endoscope and accessories 1,2 An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body
cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces
and may include an optical system for conveying an image to the user's eye and t heir accessories may assist in gaining access or
increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type o f device
include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular
attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes,cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, f iberoptic illuminators for endoscopes,
incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes,
ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, biopsy tissue f orceps used with
endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have been
used in other medical specialty areas or covered by endoscopes of relevant classification categories. Classi fication: (1) Class 2.
(2) Class 1 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment fo r
endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring devic e for panendoscope,
photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube,
rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope.
H.1520 Gastrointestinal Lesion
Software Detection System2 A gastrointestinal lesion software detection system is a computer- assisted detection device used in conjunction with endoscopy for
the detection of abnormal lesions in the gastrointestinal tract. This device c ontains software to assist in image detection and may
contain hardware to connect to the endoscope.
H.1620 Urodynamics measurement
system1 A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled
through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also recor d
the electrical activity of the muscles associated with urination. The device system may include transducers, electronic si gnal
conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and sp ecial
catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystom etric gas
(carbon dioxide) device, the cystometric hydra ulic device, and the electrical recording cystometer, but excludes any device that
uses air to fill the bladder.
H.1725 Gastrointestinal motility
monitoring system2 A gastrointestinal motility monit oring system is a device used to measure peristalic activity or pressure in the stomach or esophagus
by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may inc lude
signal conditioning, ampl ifying, and recording equipment. This generic type of device includes the esophageal motility monitor
and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifie r, and
external recorder.
H.1735 Electrogastrography system 2 An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric
motility disorders. The device system includes the external recorder, amplifier, skin ele ctrodes, strip chart, cables, analytical
software, and other accessories.
H.1800 Urine flow or volume
measuring system1 A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a
patient, e ither during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to
reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display
equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer,disposable nonelectric urine flow rate measuring device, and uroflowmeter.
H.2050 Prostate lesion
documentation system2 A prostate l esion documentation system is a device intended for use in producing an image of the prostate as an aid in documenting
prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image
reconstructi on software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or
stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencin g any
clinical decisions.
H.3350 Penile inflatable implant 3 A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a rese rvoir
filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manu al pump implanted in the scrotum. When the
cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.
H.3630 Penile rigidity implant 2 A penile rigidity implant is a device that consists of a pair of semi- rigid rods implanted in the corpora cavernosa of the penis to
provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.
H.3750 Testicular prosthesis 3 A testicular prosthesis is an implanted device that consists of a solid or gel- filled silicone rubber prosthesis that is implanted
surgically to resemble a testicle.
H.4020 Fiberoptic light ureteral
catheter2 A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped
so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.
H.4270 Colostomy rod 2 A colostomy rod is a device used during the loop colostomy procedur e. A loop of colon is surgically brought out through the
abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back throug h
the surgical opening.
H.4300 Endoscopic electrosurgical
unit and accessories2 An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscop e.
This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, f lexible snare,
electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self- opening rigid snare, flexible suction
coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instru ments, the electric
cord for transurethral surgical instruments, and the transurethral desiccator.
H.4370 Gastroenterology -urology
evacuator1,2 A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological
procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered
bladder evacuator, and the AC-powered vacuum pump. Classification: (1) Class 2 devices for the gastroenterology- urology
evacuator when other than manually powered ;(2) Class 1 devices for the gastroenterology- urology evacuator when manually
powered.
H.4400 Hemorrhoidal ligator 2 A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal t issue by means of a ligature or band placed
around the hemorrhoid.
H.4480 Electrohydraulic lithotriptor 2 An electrohydraulic lithotriptor is an AC- powered device used to fragment urinary bladder stones. It consists of a high voltagesource connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode
is held against the stone in a water- filled bladder and repeated electrical discharges between the two poles of the electrode cause
electrohydraulic shock waves which disintegrate the stone.
H.4500 Mechanical lithotriptor 2 A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush
bladder stones.
H.4530 Gastroenterolgy-urology
fiberoptic retractor1 A gastroenterology- urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system
that is used to illuminate deep surgical sites.
H.4560 Ribdam 1 A ribdam is a device that consi sts of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine
drainage is expected.
H.4590 Interlocking urethral sound 1 An interlocking urethral sound is a device that consists of two metal sounds (elongated instrum ents for exploring or sounding body
cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repa ir of
a ruptured urethra. The device may include a protective cap to fit over the metal threads.
H.4620 Ureteral stent 2 A ureteral stent is a tube- like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of
urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral
injuries and ureteral obstruction.
H.4650 Water jet renal stone
dislodger system1 A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidne y)
by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.
H.4680 Ureteral stone dislodger 1 A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandabl e wire basket near the tip, a special
flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from th e ureter.
This generic type of device includes the metal basket and the flexible ureteral stone dislodger.
H.4730 Manual gastroenterolgoy-
urology surgical instrument
and accessories1 A manual gastroenterology- urology surgical instrument and accessories is a device designed to be used for gastroenterological and
urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered
rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro- urology hook,
gastro-urology probe and director, nonself- retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck
spreader, self-retaining retractor, and scoop.
H.4770 Urethrotome 2 A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It i s a metal
instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath . Some urethrotomes incorporate an
optical channel for visual control.
H.4890 Urological table and
accessories1,2 A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a s uitable
positio n for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.Classification: (1) Class 2 devices for the electrically powered urological table and accessories ;(2) Class 1 devices for the manuall y
powered table and accessories, and for stirrups for electrically powered table.
H.5010 Biliary catheter and
accessories2 A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract , for
splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may incl ude a bile
collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
H.5015 Pancreatic drainage stent 2 A pancreatic drainage stent is a device that consists of a self- expanding, covered, metallic stent, intended for placement to facilitate
transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be rem oved upon confirmation of pseudocyst
resolution. This device may also include a delivery system.
H.5020 External penile rigidity
devices2 External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual in tercourse. External
penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneuma tic
devices.
H.5025 Vibrator for climax control
of premature ejaculation2 A vibrator for climax control of pr emature ejaculation is used for males who suffer from premature ejaculation. It is designed to
increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.
H.5030 Continent ileostomy
catheter1 A continent ileostomy catheter is a flexible tubular device used as a form during surgery for continent ileostomy and it provides
drainage after surgery. Additionally, the device may be inserted periodically by the patient for routine care to empty the ileal p ouch.
This generic type of device includes the rectal catheter for continent ileostomy.
H.5090 Suprapubic urological
catheter and accessories1,2 A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the ab dominal wall into the
urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This g eneric
type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube,
and the suprapubic cannula and trocar. Classification: (1) Class 2 ;(2)Class 1 devices for the catheter punch instrument,
nondisposable cannula and trocar, and gastro-urological trocar.
H.5130 Urological catheter and
accessories1,2 A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass flui ds to or
from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, ur ethral catheters,
coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female
urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter acces sories including
ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral cathete rization trays,
and the gastro-urological irrigation tray (for urological use). Classification: (1) Class 2 ;(2) C lass 1 devices for the ureteral stylet
(guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder.
H.5140 Urethral insert with pump
for bladder drainage2 A urethral insert with pump for bladder drainage is a catheter- like device with internal pump mechanism that is placed in the
urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flo w
when continence is desired . The device is intended for use by women who cannot empty their bladder due to impaired detrusorcontractility.
H.5160 Urological clamp for males 1 A urological clamp for males is a device used to close the urethra of a male to control urinary incontinen ce or to hold anesthetic
or radiography contrast media in the urethra temporarily. It is an external clamp.
H.5210 Enema kit 1 An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to p romote
evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either di rectly
or via tubing. This device does not include the colonic irrigation system (H.5220).
H.5220 Colonic irrigation system 2,3 A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse
(evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon d uring the
administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes
a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The dev ice may include a
console- type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use
electrical power to heat the water. The device does not include the enema kit (H.5210). Classification: (1) Class 2 devices intended
for colon cleansing when medically indicated, such as before radiological or endoscopic examinations ;(2)Class 3 devices intended
for other uses, including colon cleansing routinely for general well being.
H.5250 Urine collector and
accessories1,2 (a)A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suit able
receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection.
The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling cathete r,
which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag. (2) A ur ine collector
and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatri c
urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)Classification: (1) Class 2 for a urine collector and accessories intended to be connected to an indwelling catheter ;(2) Class
1 for a urine collector and accessories not intended to be connected to an indwelling catheter.
H.5270 Implanted electrical urinary
continence device3 An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver
implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor,
and a battery-powered transmitter outside the body.
H.5280 Implanted
mechanical/hydraulic
urinary continence device3 An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incont inence by the application of
continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad , or a
system with a container of radiopaque fluid in the abdomen and a manual pump and valve under th e skin surface that is connected
by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate
the pad or cuff to pass on the urethra.
H.5310 Nonimplanted, peripheral 2 A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an ele ctricalelectrical continence device cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripher al location and used to
stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be
removed by the user.
H.5320 Nonimplanted electrical
continence device.2 A nonimplanted electrical cont inence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected
by an electrical cable to a powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to
stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be
removed by the user. This classification excludes an AC- powered nonimplanted electrical continence device and the powered
vaginal muscle stimulator for therapeutic use (L.5940).
H.5365 Esophageal dilator 2 An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a
metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This
generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).
H.5450 Rectal dilator 1 A rectal dilator is a device designed to dilate the anal sph incter and canal when the size of the anal opening may interfere with its
function or the passage of an examining instrument.
H.5470 Ureteral dilator 2 A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to di late the ureter at the place where
a stone has become lodged or to dilate a ureteral stricture.
H.5520 Urethral dilator 1,2 A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable mate rial
in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the
device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device
includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and fi liform
follower. Classification: (1) Class 2 ;(2) Class 1 for the urethrometer, urological bougie, filiform and filiform follower, and metal
or plastic urethral sound.
H.5530 Implantable transprostatic
tissue retractor system2 An implantable transprostatic tissue retractor system is a device that consists of a delivery device and implant. The deliver y device
is inserted tr ansurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by
providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for t he
treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.
H.5540 Blood access device and
accessories1,2 (a)A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialys is or other
chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal f ailure
or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted b lood access
devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access
devices.(1) The implanted blood access device is a device and consists of various flexible or rigid tubes, such as catheters, or
cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remainin the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically
designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous
port-catheter systems, and A- V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings
or additives whic h may provide additional functionality to the device. (2)The nonimplanted blood access device consists of
various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood ves sels
or a vascular graft prosthesis, and are intended to remain in the body for less than 30 days. This generic type of device includes
fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow
needle).(3)Accessorie s common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer,
vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declot ting
tray (including contents).
(b)Classification: (1) Class 2 for the implanted blood access device; (2)Class 2 for the nonimplanted blood access device; (3)
Class 2 for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph.(4) of this
section.; (4)Class 1 for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories
for both the implanted and nonimplanted blood access device.
H.5600 Sorbent regenerated
dialysate delivery system for
hemodialysis2 A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the
treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate
dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal bl ood
system and the dialyzer of the hemodialysis system and accessories. The device includes the means to maintain the temperature,
conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditi ons. The
sorbent cartridge may include absorbent, ion exchange and catalytic materials.
H.5630 Peritoneal dialysis system
and accessories2 (1)A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients
with renal failure or toxemic conditions, and that consists of a peritoneal access device, an admi nistration set for peritoneal dialysis,
a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient' s peritoneal
cavity, it is allowed to dwell there so that undesirable substances from the p atient's blood pass through the lining membrane of the
peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The
peritoneal dialysis system may regulate and monitor the dialysate temperatur e, volume, and delivery rate together with the time
course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This gener ic
device includes the semiautomatic and the automatic peritoneal delivery syst em.(2)The peritoneal access device is a flexible tube
that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and
a skin seal. The device is either a single use peritoneal catheter, inte nded to remain in the peritoneal cavity for less than 30 days,
or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an ob turator tomaintain the patency of the surgical fistula in the abdom inal wall between treatments.(3)The disposable administration set for
peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal di alysate
filter to trap and remove contaminating particles.(4) The source of dialysate may be sterile prepackaged dialysate (for
semiautomatic peritoneal dialysate delivery systems or "cycler systems") or dialysate prepared from dialysate concentrate and
sterile purified water (for automatic peritoneal dialysate deliv ery systems or "reverse osmosis" systems). Prepackaged dialysate
intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
H.5665 Water purification system
for hemodialysis2 A water purification system for h emodialysis is a device that is intended for use with a hemodialysis system and that is intended
to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form
dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
H.5820 Hemodialysis system and
accessories1,2 (a)A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatme nt of patients with
renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate
delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood sy stem and
accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system
to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in th e
blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the
dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate
compartmen t of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors,
air foam or bub ble detectors, and alarms to keep blood moving safely from the blood access device and accessories for
hemodialysis ( H.5540 ) to the blood compartment of the dialyzer and back to the patient.(2) The conventional dialyzer allows
a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable
membrane of the conventional d ialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not
required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyze rs
with the disposable inserts (Kiil type) or dialyzers of high permeability.(3) The dialysate delivery system consists of
mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates
dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate
for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does
not include the sorbent regenerated dialysate delivery system for hemodialysis (H.5600 ), the dialysate delivery system of the
peritoneal dialysis system and accessories, or the controlled dialysate delivery system of the high permeability hemodialysis
system (H.5860).(4) Remote accessories to the hemodial ysis system include the unpowered dialysis chair without a scale, the
powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)Classification: (1) Class 2 for hemodialysis systems and acc essories that are directly related to the extracorporeal bloodsystem, and the dialysate delivery system ;(2) Class 1 for extracorporeal blood system and dialysate delivery system that
remote hemodialysis system and other accessories, such as non-powered d ialysis chair, hemodialysis start/stop tray, dialyzer
holder set and dialysis tie gun and ties.
H.5830 Hemodialyzer with
disposable insert (kiil type)2 A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificia l kidney system for the treatment
of patients with renal failure or toxemic conditions. The device include multiple layers of semipermeable membranes that consists
of disposable inserts (filters). It is intended to use with the extracorporeal blood system and the dialysate delivery system of the
hemodialysis system and accessories (H.5820).
H.5860 High permeability
hemodialysis system2 A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients
with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration,
hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water
than the semipermeable membrane of the conventional hemodialysis system, the high permeability hemodialysis system removes
toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or d iffusion
(via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood
compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins an d/or
fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine
controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped throug h
the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of th e
following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (Kuf )
greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, a nd
is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalan ce.(2)
The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodial ysissystem and accessories, with the addition of an ultrafiltration controller and mechanisms that monitor and/or control s uch
parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea,
etc.).(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various trea tment
related monitors (e.g., dialysate pH, blood pressure, hematocrit, blood recirculation monitors, etc.).
H.5870 Sorbent hemoperfusion
system3 A sorbent hemoperfusion system is a device that consists of an extracorporeal blood system similar to that identified in the
hemodialysis system and accessories and a container filled with adsorbent material that removes a wide range of substances, b oth
toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resi ns which may be
coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines an d filters
specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning,
drug overdose, hepatic coma, or metabolic disturbances.
H.5880 Isolated kidney perfusion
and transport system and
accessories2 An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney
and to maintain the organ in a near- normal physiologic state until it is transplanted into a recipient patient. This generic type of
device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile
or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set. The item
includes the preservation solutions for organs. This item is not intended for organ perfusion and delivery systems use in other
specialties.
H.5885 Tissue culture media for
human ex vivo tissue and
cell culture processing
applications2 Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cel l and tissue culture media and
components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts, etc. ) that are
essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin . The solutions are indicated
for use in human ex vivo tissue and cell culture processing applications.
H.5895 Ostomy irrigator 2 An ostomy irrigator is a device that consists of a container for fluid, tubing with a cone-shaped tip or a soft and flexible catheter
with a retention shield and that is used to wash out the colon through a colostomy, a surgically created opening of the colon on the
surface of the body.
H.5900 Ostomy pouch and
accessories1 An ostomy pouch and accessories is a device that consi sts of a bag that is attached to the patient's skin by an adhesive material and
that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or uret erostomy
(a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of
device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector,
colostomy pouch, urinary ileostomy bag , urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag,
ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.
H.5930 Rectal control system 2 A rectal control system is a device intended to treat fecal incontinence by controlling the size of the rectal lumen. The device is
inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts t o allownormal passage of stool. The device includes an external regulator to control the state of expansion.
H.5955 Peritoneo-venous shunt 2 A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter
is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the pe ritoneal
cavity to flow into the venous system for the treatment of intractable ascites.
H.5970 Hernia support 1 A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening
(a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the
umbilical truss.
H.5980 Gastrointestinal tube and
accessories1,2 A gastrointestinal tube and accessories is a device that consists of flexible or semi- rigid tubing used for instilling fluids into,
withdrawing fluids from, splinting, or suppressing bleeding of the al imentary tract. This device may incorporate an integral
inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspir ation
catheter (gastric, colonic, etc.), rectal catheter, sterile infant ga vage set, gastrointestinal string and tubes to locate internal bleeding,
double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube,
single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro- urological irrigation tray
(for gastrological use).Classification: (1)Class 2 ;(2)Class 1 for the dissolvable nasogastric feed tube guide for the nasogastric tube.
H.5990 Extracorporeal shock wave
lithotripter2 An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively frag ment
urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high volta ge
generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using
either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic sp ark
discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone wi th
either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave
generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragme nted by
the focused shock waves, the fragments pass out of the body with the patient's urine.
H.9999 Others(Gastroenterology
and Urology Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
I.0001 High density electrical
current subcutaneous
wrinkle reduction device2 A device with high density electrical current for subcutaneous wrinkle reduction is a device applying an electrical current to
electrodes on a patient's skin up to subdermal or muscle layers for reducing body wrinkles and connective tissue swelling by
physical acti on. This device applies high density electrical current to stimulate collagen and elastin production by heating tissues
in the deep layers of the skin.
I.0002 Collagen implant 3 A collagen implant is a device primarily composed of collagen to correct or b e implanted in facial or other body surface where
weakness exists.
I.0003 Ultrasonic surgical 2 An ultrasonic surgical instrument is a surgical device for soft tissue ablation. This device contains ultrasound generator an dinstrument accessories including control console, ultrasound applicator(s), foot switch, and waste collector.
I.0004 Alcohol pad 2 An alcohol pad is a non-absorbable piece of cotton containing alcohol used for, e.g., skin cleaning, disinfection and medical
purposes.
I.0005 Providone-Iodine pad 2 A Providone-Iodine pad is a non-absorbable piece of cotton containing Providone-Iodine used for, e.g., skin cleaning, disinfection
and medical purposes.
I.0006 Medical protective clothing 2 Medical protective clothing are devices that are inten ded to be worn by medical personnel in medical environments. These devices
protect medical personnel from cross- infection. These devices are to protect whole or part of the body from the environments.
Surgical gowns are not included in this identification. Classification: Class 2.
I.0007 Hyaluronic Acid Implants 3 Hyaluronic acid implants are hyaluronic acid substances used to modify or filled into surface defects on the face or other bo dy
positions.
I.0008 Transcutaneous skin
stimulator2 A transcutaneous skin stimulator applies energy (e.g., electrical current, optical energy, ultrasound energy, etc. ) on a patient's skin
up to dermal or subdermal layers to modify skin appearance (e.g., skin tightening, toning, lifting, reducing wrinkles, etc. ) or to
stimulate collagen or cell production.
I.0009 High Intensity Focused
Ultrasound (HIFU) Ablation
System3 An high intensity focused ultrasound (HIFU) ablation system is intended to use HIFU to ablate soft tissue or specific cell ti ssue.
The system needs to be used with medical imaging systems (e.g., MR imaging systems, etc.) used for guiding the procedure.
I.0010 Adhesion Barrier Material 3 Adhesion barrier material, which can be in the form of colloid or film, as a temporary physical barrier to separate tissu es to reduce
fibrosis and reduce the formation of adhesions. It can be used in general surgical sites, not in other specialty areas or the one that
already has adhesion barrier materials in related categories.
I.1800 Speculum and accessories 1 A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and
may have various accessories.
I.3250 External facial fracture
fixation appliance1 An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to
immobilize maxillofacial bone fragments in their proper facial relationship.
I.3300 Surgical mesh 2 Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.
Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used
during orthopedic surgery.
I.3500 Polytetrafluoroethylene with
carbon fibers composite
implant material2 A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted
during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space- occupying
substance and is shaped and formed by the surgeon to conform to the patient's need.
I.3530 Silicone inflatable breast 3 A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane andprosthesis polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The dev ice is
intended to be implanted to augment or reconstruct the female breast.
I.3540 Silicone gel-filled breast
prosthesis3 (1)Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel- filled breast prosthesis is a silicone rubber shell
made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-
linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at tim e of
implantation. The device is intended to be implanted to augment or reconstruct the female breast. (2)Double-lumen silicone gel-
filled breast prosthesis. A double lumen silicone gel- filled breast prosthesis is a silicone rubber inner shell and a silicone rubber
outer shell, both shells made of polysiloxane(s), such as polydi-methylsiloxane and polydip henylsiloxane. The inner shell contains
fixed amounts of cross- linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with
sterile isotonic saline before or after implantation. The device is intended to b e implanted to augment or reconstruct the female
breast. (3)Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel- filled breast prosthesis is
an inner silicone rubber shell made of polysiloxane(s), such as polydime thylsiloxane and polydiphenylsiloxane, with an outer
silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross -linked
polymerized silicone gel, fillers, and stabilizers and an inert support s tructure compartmentalizing the silicone gel. The device is
intended to be implanted to augment or reconstruct the female breast.
I.3550 Chin prosthesis 2 A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
I.3590 Ear prosthesis 2 An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
I.3610 Esophageal prosthesis 2 An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is
intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be
uncovered or covered with a polymeric material. This device may also include a device delivery system.
I.3680 Nose prosthesis 2 A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.
I.3720 Tracheal prosthesis 2 The tracheal prosthesis is a rigid, flexible, or expa ndable tubular device made of a silicone, metal, or polymeric material that is
intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranc hed or
contain one or two branches. The metal trache al prosthesis may be uncovered or covered with a polymeric material. This device
may also include a device delivery system.
I.3800 External aesthetic
restoration prosthesis1 An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such
as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external
prosthesis adhesive. The device is not intended to be implanted.
I.3900 Inflatable extremity splint 1 An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.
I.3910 Noninflatable extremity
splint1 A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.I.3925 Plastic surgery kit and
accessories1 A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit cont ains
surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
I.4010 Tissue adhesive 2,3 (a)Tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, incl uding
laparoscopic incisions, and simpl e traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical
approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches. Classification: Class 2.
(b) A tissue adhesive for non-topi cal use, including adhesives intended for use in the embolization of brain arteriovenous
malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels. Classification: Class
3.
I.4011 Tissue adhesive with
adjunct wound closure
device for topical
approximation of skin2 A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical
application only to hold closed easily approximated skin edge s of wounds from surgical incisions, including punctures from
minimally invasive surgery, and simple, thoroughly cleansed, trauma- induced lacerations. It may be used in conjunction with, but
not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge
alignment along the length of wound during application of the liquid adhesive..
I.4014 Nonresorbable
gauze/sponge for external
use1,2 A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed
directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh
cotton cellulose or a simple chemical derivative of cellulose. Classification: Class 1. This classification does not include a
nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as
growth factors, or is composed of materials derived from animal sources. Classification: Class 2.
I.4015 Wound dressing with poly
(diallyl dimethyl ammonium
chloride) (pDADMAC)
additive2 A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2n d degree
burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.
I.4018 Hydrophilic wound dressing 1,2 A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consi sts of
nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives,
alginates, dextran, and rayon). Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound , free
sewing(replacing surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors, or is
composed of materials derived from animal sources. ;(2)Class 1 other devices.
I.4020 Occlusive wound/burn
dressing1,2 An occlusive wound dressing is a nonresorbable, sterile or non- sterile device intended to cover a wound, to provide or support a
moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists o f
a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. Classification: (1)Class 2
devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture), contain added drugs suchas antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. ;(2)Class
1 other devices.
I.4022 Hydrogel wound dressing
and burn dressing1,2 A hydrogel wound dressing is a sterile or non-st erile device intended to cover a wound, to absorb wound exudate, to control
bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorb able matrix
made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate.
Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free sewing(replacing surgical suture),
contain added drugs such as antimicr obial agents, added biologics such as growth factors, or is composed of materials derived
from animal sources. ;(2)Class 1 other devices.
I.4025 Silicone scar management
product1 Silicone scar management product is intended for use in the management of closed hyperproliferative (hypertrophic and keloid)
scars.
I.4040 Medical apparel 1,2 Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both
the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns.
Surgical suits and dresses, commonly known as scrub suits, are excluded. Classification: (1) Class 2 devices intended for
surgical procedure including surgical gowns and surgical masks. (2) Class 1 other devices. Medical masks are required to meet
performance requirements from the national standard CNS 14774(T5017).
For medical masks that are labelled/claimed to have the equivalent or above effect of TN95 or N95, the sub-micron particulate
filtration efficiency and exhalation/inhalation resistance of airflow (replacing “differential pressure” test) of the mask should be
in accordance with TN95 class (or higher) performance requirements from disposable dust-proof masks of the national standard
CNS 14755 (Z2125).
I.4100 Organ bag 1 An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical
procedures to prevent moisture loss.
I.4160 Surgical camera and
accessories1 A surgical camera and accessories is a device intended to be used to record operative procedures.
I.4165 Wound autofluorescence
imaging device2 A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an
excitation light. The device is not intended to provide quantitative or diagnostic information.
I.4200 Introduction/drainage
catheter and accessories1 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce n ondrug
fluids into body cavities other than blood vessels, drain fluids from body c avities, or evaluate certain physiologic conditions.
Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general
surgical catheters. An introduction/drainage catheter accessory is in tended to aid in the manipulation of or insertion of the device
into the body. Examples of accessories include adaptors, connectors, and catheter needles.
I.4300 Implantable clip 2 An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
I.4320 Removable skin clip 1 A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.I.4340 Contact cooling system 2 A contact cooling syste m is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager
intended for the disruption of adipocyte cells intended for non-invasive use.
I.4350 Cryosurgical unit and
accessories2 (1)Cryosurgical unit with a liqu id nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled
cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme
cold.(2)Cryosurgical unit with a nitrous oxide c ooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled
cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological application s, by
applying extreme cold.(3)Cryosurgical unit w ith a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and
accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessorie s is
a device intended to destroy tissue during su rgical procedures by applying extreme cold. The device is intended to treat disease
conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels)
and various benign or malignant gynecological c onditions affecting vulvar, vaginal, or cervical tissue. The device is not intended
for urological applications.
I.4360 Scalp cooling system to
reduce the likelihood of
chemotherapy-induced
alopecia2 A scalp cooling system to reduce the likelihood of chemotherapy- induced alopecia is a device intended to reduce the frequency
and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
I.4370 Surgical drape and drape
accessories1,2 (a) A surgical drape and drap e accessories is a device made of natural or synthetic materials intended to be used as a protective
patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic
wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a
latex drape with a self- retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during
performance of a transurethral prostatectomy.
(b) Classification: (1) Class 2. (2) Class 1 for drape and cover intended for medical device covering.
I.4371 Irrigating wound retractor
device2 An irrigating wound retractor device is a device intended to be used by a surgeon to retract the surgical incision, to provide access
to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the su rgical
wound.
I.4380 Drape adhesive 1 A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
I.4400 Electrosurgical cutting and
coagulation device and
accessories2 An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleedi ng by
use of high-frequency electrical current.
I.4410 Low energy ultrasound
wound cleaner2 A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is
used for the cleaning and mainten ance debridement of wounds. Low levels of ultrasound energy may be carried to the wound bythe saline mist.
I.4440 Eye pad 1 An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a band age
over the eye for protection or absorption of secretions.
I.4450 Nonabsorbable gauze for
internal use1 Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgica l
incision or applied to int ernal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion,
drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a
simple chemical derivative of cellulose, and contains x-ray detectable elements.
I.4454 Non-absorbable, hemostatic
gauze for temporary internal
use2 A non-absorbable , hemostatic gauze for temporary internal use is a device intended to be placed temporarily for control of se verely
bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material
which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.
I.4460 Surgeon's glove 1,2 A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a
surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. A surge on's glove containing
biodegradable powders which complies with U.S.P. (for example corn powders) is class 2 device. Non- clinical performance data
of the barrier property (water leak) and tensile strength should comply with ISO 10282, ASTM D 3577, EN 455 o r equivalent
standards. A non- powdered (powder free) surgeon's glove should comply with EN ISO 21171, ASTM D 6124 or equivalent
standards. The average amount of residual powders on a glove should not exceed 2.0 mg.
I.4470 Surgeon's gloving cream 1 Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's glove.
I.4480 Absorbable powder for
lubricating a surgeon's glove3 Absorbable powder for lubricating a surgeon's glove is a powder made from co rn starch that meets the specifications for absorbable
powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon's hand before putt ing
on a surgeon's glove. The device is absorbable through biological degradation.
I.4490 Absorbable hemostatic
agent and dressing3 An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of
blood. It is absorbable.
I.4493 Absorbable poly
(glycolide/L-lactide)
surgical suture2 An absorbable poly(glycolide/l- lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and
synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent L-lactid e, and is
indicated for use in soft tissue approximation. It may be monofilament or multifilament (braided) in form; it may be uncoated or
coated; and it may be undyed or dyed with an FDA -approved color additive. Also, the suture may be provided with or wi thout a
standard needle attached.
I.4494 Absorbable
poly(hydroxybutyrate)
surgical suture produced by
recombinant DNA2 An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokary otic
cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue
approximation and ligation. Also, the suture may be provided with or without a standard needle attached.technology
I.4495 Stainless steel suture 2 A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-
0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, i ntestinal
anastomosis, hernia repair, and sternal closure.
I.4520 Polytetrafluoroethylene
injectable3 Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to b e used
to augment or reconstruct a vocal cord.
I.4580 Surgical lamp 2 A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field o r the
patient.
I.4590 Focused ultrasound
stimulator system2 A Focused Ultrasound Stim ulator System is a device using focused ultrasound to produce localized, mechanical motion within
tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular mem brane
disruption intended for noninvasive use.
I.4630 Ultraviolet lamp for
dermatologic disorders2 An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body
to photoactivate a drug in the treatment of a dermato logic disorder if the labeling of the drug intended for use with the device bears
adequate directions for the device's use with that drug.
I.4650 Aorto-saphenous vein ostia
marker2 An Aorto-saphenous vein ostia marker is used as a landmark to identify th e anastomosis site of the vein utilizing fluorscopy. The
marker is surgically attached to a anastomosis sites of the vein graft.
I.4660 Skin marker 1 A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline s urgical incision sites or mark
anatomical sites for accurate blood pressure measurement.
I.4670 Internal tissue marker 2 An internal tissue marker is a use device that is intended for use prior to or during general surgical procedures to demarcate selecte d
sites on internal tissues.
I.4680 Nonpowered, single patient,
portable suction apparatus1 A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable
evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
I.4683 Non-Powered suction
apparatus device intended
for negative pressure wound
therapy2 A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicate d for wound
management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluid s,
and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
I.4685 Extracorporeal shock wave
device for treatment of
chronic wounds3 An extracorporeal shock wave device for treatment of chronic wounds is a device that focuses acoustic shock waves onto the
dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.
I.4700 Surgical microscope and 1 A surgical microscope and accessories is an AC- powered device intended for use during surgery to provide a magnified view ofaccessories the surgical field.
I.4730 Surgical skin degreaser or
adhesive tape solvent1 A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-
trifluoroethane; 1,1,1 -trichloroethane; and 1,1,1 -trichloroethane with mineral spirits inten ded to be used to dissolve surface skin
oil or adhesive tape.
I.4750 Implantable staple 2 An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
I.4760 Removable skin staple 1 A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.
I.4780 Powered suction pump 2 A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious
materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in
the operating room or at the patient's bedside. The device may include a microbial filter.
I.4800 Manual surgical instrument
for general use1 A manual surgical instrument for general use is a nonpowered, hand-held, or hand- manipulated device, either reusable or
disposable, intended to be used in various general surgical procedures. The device includes the app licator, clip applier, biopsy
brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissect or,
elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemo stat, amputation hook, ligature
passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection equipment ,
disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one- piece
scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring
tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations
in parts D through P.
I.4810 Laser surgical instrument
for use in general and plastic
surgery and in dermatology2 A laser device for use in general surgery, plastic surgery and dermatology is a laser device intended to cut, destroy, or remove
tissue by light energy.
I.4815 Magnetic surgical
instrument system2 A magnetic surgical instrument system is a device used in laparoscopic surgical procedures consisting of several components, such
as surgical instrum ents, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and
is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s ) at the
surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs.
I.4820 Surgical instrument motors
and accessories/attachments1 Surgical instrument motors and accessories/attachments are AC-powered, battery-powered, or air-powered devices in tended for
use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft
tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead,
pin driver, and saw blade. This item not suitable for devices used for skull and spine surgery.
I.4830 Absorbable surgical gut
suture2 An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prep ared from either the serosal
connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in softtissue approximation.
I.4840 Absorbable polydioxanone
surgical suture2 An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from poly dioxanone
and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to o ccur,
and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.
I.4930 Suture retention device 1 A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to a id wound healing
by distributing suture tension over a larger area in the patient.
I.4950 Manual operating table and
accessories and manual
operating chair and
accessories1 A manual operating table and accessories and a manual operating chair and accesso ries are nonpowered devices, usually with
movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
I.4960 Operating tables and
accessories and operating
chairs and accessories1 Operating tables and accessories and operating chairs and accessories are AC-powered or air- powered devices, usually with
movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.
I.5000 Nonabsorbable
poly(ethylene
terephthalate)surgical suture2 Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepar ed from
fibers of high molecular weight, long-chain, linear polyesters having recurrent a romatic rings as an integral component and is
indicated for use in soft tissue approximation. It may be undyed or dyed with an appropriate FDA listed color additive. Also, the
suture may be provided with or without a standard needle attached.
I.5010 Nonabsorbable
polypropylene surgical
suture2 Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long- chain
polyolefin polymer known as polypropylene and is indicated for use in soft tissue appro ximation. It may be undyed or dyed with
an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
I.5020 Nonabsorbable polyamide
surgical suture2 Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long- chain aliphatic polymers
Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. It may be provided uncoated or coated; and it ma y be
undyed or dyed with an appropriate FDA listed color add itive. Also, the suture may be provided with or without a standard needle
attached.
I.5030 Natural nonabsorbable silk
surgical suture2 Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an o rganic protein
called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural
nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk s urgical suture may
be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Also, the suture may be provided with or without a standard needle attached.
I.5035 Nonabsorbable expanded
polytetrafluoroethylene2 Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible
thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. Itsurgical suture may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).
I.5040 Suction lipoplasty system 2 A suction lipoplasty system is a device intended for aesthetic body co ntouring. The device consists of a powered suction pump
(containing a microbial filter on the exhaust and a microbial in- line filter in the connecting tubing between the collection bottle
and the safety trap), collection bottle, cannula, and connecting tub e. The microbial filters, tubing, collection bottle, and cannula
must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower,
a variable vacuum range from 0 to 29.9 inches of mercury, vacuum cont rol valves to regulate the vacuum with accompanying
vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and
a safety trap.
I.5070 Air-handling apparatus for a
surgical operating room2 Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that ha s
been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possi bility of
infection in the patient.
I.5350 Needle-type epilator 1 A needle- type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine
needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-
frequency AC current, high-frequency AC combined with DC current, or DC current only.
I.5360 Tweezer-type epilator 1 The tweezer-type epilator is an electrical device intended t o remove hair. The energy provided at the tip of the tweezer used to
remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.
I.5400 Low level laser system 2 A Low Level Laser System is a devi ce using low level laser energy for the disruption of adipocyte cells within the fat layer for the
release of fat and lipids from these cells for noninvasive use. Classification. Class 2.
I.5650 Topical oxygen chamber for
extremities3 A topical oxygen ch amber for extremities is a device intended to surround hermetically a patient's limb and apply humidified
oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
I.5900 Nonpneumatic tourniquet 1 A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tigh tened
to reduce circulation.
I.5910 Pneumatic tourniquet 1 A pneumatic tourniquet is an air-powered device consisting of a pressure- regulating unit, connecting tubing, and an inflatable cuff.
The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
I.9999 Others(General and Plastic
Surgery Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
J.0001 Saline solution for wound
irrigation2 Wound irrigation saline is a normal saline solution which uses physical means to clean the surface of a shallow skin wound.
J.0003 Medical Pressure Garment 1 Medical Pressure Garment apply to the skin surface and insert moderate and balanced pressure to support and compress the medical
equipment covered on the patient's body parts, so as to achieve the effect of pressure medical treatment.J.0004 Ozone Disinfector 2 Disinfect medical devices by generating ozone gas or ozone water.
J.2200 Liquid crystal forehead
temperature strip1 A liquid crystal forehead temperat ure strip is a device applied to the forehead that is used to indicate the presence or absence of
fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corres ponding
to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.
J.2420 Electronic monitor for
gravity flow infusion
systems2 An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient.
The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.
J.2460 Electrically powered spinal
fluid pressure monitor2 An electrically powered spinal fl uid pressure monitor is an electrically powered device used to measure spinal fluid pressure by
the use of a transducer which converts spinal fluid pressure into an electrical signal. The device includes signal amplificat ion,
conditioning, and display equipment.
J.2500 Spinal fluid manometer 2 A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserte d into
the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading
the height of the fluid.
J.2750 Image processing device for
estimation of external blood
loss2 An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external
blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to
estimate the hemoglobin mass and/or the blood volume present in the images.
J.2800 Sterilization process
indicator2 (a)Biological sterilization process indicator -- (1)Identification: A biological sterilization process indicator is a device intended for
use by a health care provider to accompany products being sterilized through a sterilization procedure and to mon itor adequacy of
sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on
a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow u nder suitable
conditions indicates the adequacy of sterilization.(2)Classification: Class 2.(b)Physical/chemical sterilization process indicator --
(1)Identification: A physical/chemical sterilization process indicator is a device intended for use by a heal th care provider to
accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilizat ion
process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a vis ible change in the device.
(2)Classification: Class 2.
J.2900 Clinical color change
thermometer1 A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) bod y
temperature. The device record s body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or
metal strip. Body heat causes a stable color change in the heat sensitive chemicals.
J.2910 Clinical electronic
thermometer2 A clinical electronic thermomet er is a device used to measure the body temperature of a patient by means of a transducer coupled
with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without
a disposable cover.J.2920 Clinical mercury
thermometer1 A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the ther mal
expansion of mercury.
J.5025 I.V . container 2 An I.V . container is a container made of plast ic or glass used to hold a fluid mixture to be administered to a patient through an
intravascular administration set.
J.5045 Medical recirculating air
cleaner2 A medical recirculating air cleaner is a device used to remove particles from the air for medi cal purposes. The device may function
by electrostatic precipitation or filtration.
J.5075 Elastic bandage 1,2 An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to suppo rt and
compress a part of a patient's body. Classification: (1) Class 2: devices that are intended for third degree burns, stitch- free (replacing
surgical suture), drugs or biological reagents (e.g., growth hormone), containing antibacterial ingredients, etc. ;(2) Class 1: o ther
devices.
J.5090 Liquid bandage 1,2 A liquid bandage is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dress ing
for burns. The device is also used as a topical skin protectant.Classification: (1)Cla ss 2 devices that are intended for patients with
class 3 burning wound, free sewing(replacing surgical suture), contain added drugs such as antimicrobial agents, added biolog ics
such as growth factors, or is composed of materials derived from animal sources. ;(2)Class 1 other devices.
J.5100 AC-powered adjustable
hospital bed1 An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built- in electric
motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device
includes movable and latchable side rails.
J.5110 Hydraulic adjustable
hospital bed1 A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism
operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
J.5120 Manual adjustable hospital
bed1 A manual adjustable hospital bed is a device intend ed for medical purposes that consists of a bed with a manual mechanism
operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.
J.5130 Infant radiant warmer 2 The infant radiant wa rmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain
the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat o utput
control mechanism , and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a
temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively.
The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.
J.5140 Pediatric medical bed 1 A pediatric medical bed is intended for medical purposes for use with a pediatric patient that consists of an open crib, fixe d end
rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may
be adjustable.
J.5150 Nonpowered flotation
therapy mattress1 A nonpowered flotation therapy mattress is a mattress intended for medic al purposes which contains air, fluid, or similar materials
that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The de viceis intended to treat or prevent decubitus ulcers (bed sores).
J.5160 Therapeutic medical binder 1 A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secure d by
ties so that it supports the underlying part of the body or holds a dressing in place. This g eneric type of device includes the
abdominal binder, breast binder, and perineal binder.
J.5180 Burn sheet 1,2 A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound
exudate, and to ser ve as a barrier against contaminants. Classification: (1) Class 2 devices that are intended for third degree burns,
stitch-free (replacing surgical suture), drugs or biological reagents (e.g., growth hormone), containing antibacterial ingredients,
etc.;(2) Class 1 other devices.
J.5200 Intravascular catheter 2 An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inser ted into
the patient's vascular system for short term use (less than 30 d ays) to sample blood, monitor blood pressure, or administer fluids
intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
J.5210 Intravascular catheter
securement device1 An intravascular catheter sec urement device is a device with an adhesive backing that is placed over a needle or catheter and is
used to keep the hub of the needle or the catheter flat and securely anchored to the skin.
J.5240 Medical adhesive tape and
adhesive bandage1,2 A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material
or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The devic e is
used t o cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure
objects to the skin. Classification: (1)Class 2 devices that are intended for patients with class 3 burning wound, free
sewing(repl acing surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors, or is
composed of materials derived from animal sources. ;(2)Class 1 other devices.
J.5270 Neonatal eye pad 1 A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as
phototherapy.
J.5300 Medical absorbent fiber 1 A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a
ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body s urface.
Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.
J.5400 Neonatal incubator 2 A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled envir onment
for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add
humidity, a control valve through which oxygen may be added, and access ports for nursing care.
J.5410 Neonatal transport incubator 2 A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant
may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the
infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add
humidity, and provision for a portable oxygen bottle.J.5420 Pressure infusor for an I.V .
bag1 A pressure infusor for an I.V . bag is a device consisting of an inflatable cuff which is placed around an I.V . bag. Wh en the device
is inflated, it increases the pressure on the I.V . bag to assist the infusion of the fluid.
J.5430 Nonelectrically powered
fluid injector2 A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care pr ovider to give a hypodermic
injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the
body. It may be used for mass inoculations.
J.5440 Intravascular administration
set2 An intrav ascular administration set is a device used to administer fluids from a container to a patient's vascular system through a
needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip cham ber, an
infusion line filter, an I.V . set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a ca p to serve
as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V . bag or other infusion fluid container.
J.5450 Patient care reverse isolation
chamber2 A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harm ful
airborne material. This device protects a patient who is undergoing tre atment for burns or is lacking a normal immunosuppressive
defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of cl ean
air at a pressure greater than the air pressure outside the enclosure.
J.5475 Jet lavage 1 A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to
connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.
J.5500 AC-powered patient lift 1 An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or
other required position from one place to another, as fr om a bed to a bath. The device includes straps and slings to support the
patient.
J.5510 Non-AC-powered patient
lift1 A non-AC- powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and
transpor t a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device
includes straps and a sling to support the patient.
J.5550 Alternating pressure air
flotation mattress1 An alternating pressure air fl otation mattress is a device intended for medical purposes that consists of a mattress with multiple air
cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, an d automatic
changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).
J.5560 Temperature regulated water
mattress1 A temperature regulated water mattress is a device intended for medical purposes that consists of a mattres s of suitable size, filled
with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating componen ts,
and an optional cooling component. The temperature control may be manual or automatic.
J.5570 Hypodermic single lumen
needle2 A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the
surface of the skin. The device consists of a metal tube that is sharpened at one end and at the o ther end joined to a female connector
(hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
J.5580 Acupuncture needle 2 An acupuncture needle is a device intended to pierce the skin in the practi ce of acupuncture. The device consists of a solid, stainlesssteel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
J.5680 Pediatric position holder 1 A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes,
e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.
J.5700 Neonatal phototherapy unit 2 A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device
consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic
type of device may include supports for the patient and equipment and component parts.
J.5725 Infusion pump 2 An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may
use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also
operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may inclu de
means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
J.5740 Suction snakebite kit 1 A suction snakebite kit is a device consisting of a knife, suction device, and tourniquet used for first- aid treatment of snakebites
by removing venom from the wound.
J.5760 Chemical cold pack
snakebite kit3 A chemical cold pack snakebit kit is a device consisting of a chemical cold pack and tourniquet used for first- aid treatment of
snakebites.
J.5780 Medical support stocking 2 A medical support stocking is a device that is constructed of elastic material and designed to apply controlled pressure to the leg ,
providing pressure that gradually decreases from the ankle upwards to prevent the pooling of blood or interstitial fluid in the l egs
for medical purposes.
J.5820 Therapeutic scrotal support 1 A therapeutic scrotal support is a device intended for medical purposes that consist of a pouch attached to an elastic waistb and and
that is used to support the scrotum (the sac that contains the testicles).
J.5860 Piston syringe 2 A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At
one end of the barrel there is a male connector (nozzle) for fitting the female conne ctor (hub) of a hypodermic single lumen needle.
The device is used to inject fluids into, or withdraw fluids from the body.
J.5950 Umbilical occlusion device 1 An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood ve ssels in the umbilical cord of a newborn
infant.
J.5965 Subcutaneous, implanted,
intravascular infusion port
and catheter2 A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoi r
that connects to a long- term intravascular catheter. The device allows for repeated access to the vascular system for the infusion
of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outl et made
of metal, plastic, or combination of these materials and a long- term intravascular catheter is either preattached to the port or
attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or
multiple lumen design.J.5970 Percutaneous, implanted,
long-term intravascular
catheter2 A percutaneous, implanted, long- term intravascular catheter is a device that consists of a slender tube and any necessary connecting
fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the
vascular system for long- term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients;
the sam pling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic,
composite materials, or any combination of these materials and may be of single or multiple lumen design.
J.6025 Absorbent tipped applicator 1 An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, pape r,
or plastic stick. The device is used to apply medications to, or to take specimens from a patient.
J.6100 Ethylene oxide gas aerator
cabinet2 An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a
ventilation system designed to circulate and exchange the air in the cabinet to shorten the time re quired to remove residual ethylene
oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the
circulating air.
J.6150 Ultrasonic cleaner for
medical instruments1 An ultrasonic cleaner for m edical instruments is a device intended for cleaning medical instruments by the emission of high
frequency soundwaves.
J.6230 Tongue depressor 1 A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
J.6250 Patient examination glove 1 A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finge r to
prevent contamination between patient and examiner. Materials of patient examination gloves should comply with the barrier
property (water leak) and tensile strength requirements of ISO 11193- 1, ASTM D 3578, ASTM D 5250, ASTM D 6319, EN 455
or equivalent standards. A non-powdered (powder free) patient examination glove should comply with residual powders
requirements of EN ISO 21171, ASTM D 6124 or equivalent standards. The average amount of residual powders on a glove should
not exceed 2.0 mg.
J.6300 Implantable radiofrequency
transponder system for
patient identification and
health information2 An implantable radiofrequency transponder system for patient identification and health information is a device intended to en able
access to secure patient identification and corresponding health information. This system may include a passive implanted
transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code t hat is
read by the scanner. The identification code is used to access patient identity and corresponding health i nformation stored in a
database.
J.6375 Patient lubricant 1 A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic
or therapeutic device.
J.6430 Liquid medication dispenser 1 A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid
medication.
J.6450 Skin pressure protectors 1 A skin pressure protector is a device intended for medical purposes that is used t o reduce pressure on the skin over a bony
prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).J.6600 Ultraviolet (UV) radiation
chamber disinfection device2 An ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of non- porous
equipment surfaces by dose-controlled UV irradiation. This classification does not include self- contained open chamber UV
radiation disinfection devices intended for whole room disinfection in a health care environment.
J.6740 Vacuum-powered body fluid
suction apparatus1 A vacuum- powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered
by an external source of vacuum. This gene ric type of device includes vacuum regulators, vacuum collection bottles, suction
catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction
regulators (with gauge).
J.6775 Powered patient transfer
device1 A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, fle xible
band stretched over long rollers that can advance itself under a patient and transfer the patient with min imal disturbance in a
horizontal position to the stretcher.
J.6785 Manual patient transfer
device1 A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be plac ed
so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.
J.6820 Medical disposable scissors 1 Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of d evice
does not include surgical scissors.
J.6850 Sterilization wrap 2 A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another me dical
device that is to be sterilized by a health care provider. It is in tended to allow sterilization of the enclosed medical device and also
to maintain sterility of the enclosed device until used.
J.6860 Ethylene oxide gas sterilizer 2 An ethylene gas sterilizer is a nonportable device intended for use by a health care prov ider that uses ethylene oxide (ETO) to
sterilize medical products.
J.6870 Dry-heat sterilizer 2 A dry- heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry
heat.
J.6880 Steam sterilizer 2 A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products b y means
of pressurized steam.
J.6885 Liquid chemical
sterilants/high level
disinfectants2 A liquid chemical sterilant/high l evel disinfectant is a germicide that is intended for use as the terminal step in processing critical
and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spa ces
during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
J.6890 General purpose
disinfectants1 A general purpose disinfectant is a germicide used on the surfaces of noncritical medical devices. A general purpose disinfectant
can be used t o preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level
disinfection. Noncritical medical devices make only topical contact with intact skin surfaces.
J.6900 Hand-carried stretcher 1 A hand-carrie d stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which apatient can be carried.
J.6910 Wheeled stretcher 1 A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame th at is designed to transport patients in a
horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. Th e
frame may be fixed or collapsible for use in an ambulance.
J.6920 Syringe needle introducer 2 A syringe needle introducer is a device that uses a spring- loaded mechanism to drive a hypodermic needle into a patient to a
predetermined depth below the skin surface.
J.6960 Irrigating syringe 1 An irrigating syringe is a device intended for med ical purposes that consists of a bulb or a piston syringe with an integral or a
detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.
J.6970 Liquid crystal vein locator 1 A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of
the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).
J.6980 Vein stabilizer 1 A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so
that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein.
J.6991 Medical washer 2 A medical washer is a device that is intended for general medical purposes to clean surgical instruments, anesthesia equipmen t,
hollowware, and other medical devices.
J.6992 Medical washer-disinfector 2 A medical washer-disinfector is a device that is in tended for general medical purposes to clean, decontaminate, disinfect, and dry
surgical instruments, anesthesia equipment, hollowware, and other medical devices.
J.9999 Others(General Hospital and
Personal Use Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
K.1020 Rigidity analyzer 2 A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the e ffectiveness of drugs
or other treatments.
K.1030 Ataxiagraph 1 An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of
swaying of the body when the patient is standing erect and with eyes closed.
K.1200 Two-point discriminator 1 A two-point discriminator is a device with points used for testing a patient's touch discrimination.
K.1240 Echoencephalograph 2 An echoencephalograph is an ultrasonic scanning device (including A-scan, B-sc an, and doppler systems) that uses noninvasive
transducers for measuring intracranial interfaces and blood flow velocity to and in the head.
K.1275 Electroconductive media 2 Electroconductive media are the conductive creams or gels used with external elec trodes to reduce the impedance (resistance to
alternating current) of the contact between the electrode surface and the skin.
K.1310 Cortical electrode 2 A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stim ulating the brain or recording
the brain's electrical activity.
K.1320 Cutaneous electrode 2 A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., theelectroencephalogram) or to apply electrical stimulation.
K.1330 Depth electrode 2 A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
K.1340 Nasopharyngeal electrode 2 A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording
electrical activity.
K.1350 Needle electrode 2 A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
K.1400 Electroencephalograph 2 An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by pl acing
two or more electrodes on the head.
K.1420 Electroencephalogram EEG
signal spectrum analyzer1 An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral
density of the electroencephalogram (EEG) signal.
K.1460 Nystagmograph 2 A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
K.1480 Neurological endoscope 2 A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.
K.1500 Esthesiometer 1 An esthesi ometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician
or other examiner and which is used to determine whether a patient has tactile sensitivity.
K.1525 Tuning fork 1 A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for
vibratory sense.
K.1540 Galvanic skin response
measurement device2 A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by
measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.
K.1550 Nerve conduction velocity
measurement device2 A nerve conduction velocity measureme nt device is a device which measures nerve conduction time by applying a stimulus, usually
to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring an d
displaying the nerve conduction time.
K.1560 Skin potential measurement
device2 A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin
electrodes.
K.1570 Powered direct-contact
temperature measurement
device2 A powered direct- contact temperature measurement device is a device which contains a power source and is used to measure
differences in temperature between two points on the body.
K.1580 Non-electroencephalogram
(non-EEG) physiological
signal based seizure
monitoring system2 A non-electroencephalogram (non- EEG) physiological signal based seizure monitoring system is a noninvasive device that collects
physiological signals other than EEG to identify physiological signals that may be associated with a seizure.
K.1610 Alpha monitor 2 An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencep halogramwhich is referred to as the alpha wave.
K.1620 Intracranial pressure
monitoring device2 An intracranial pressure monitoring device is a device used for short- term monitoring and recording of intracranial pressures and
pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
K.1630 Cranial motion
measurement device2 A cranial motion measurement device is a device that utilizes accelerometers to measure the motion or acceleration of the skull.
These measurements are not to be used independently for diagnostic purposes.
K.1750 Pinwheel 1 A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.
K.1790 Ocular plethysmograph 3 An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery ,
to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).
K.1825 Rheoencephalograph 3 A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical im pedance
methods with direct electrical connections to the scalp or neck area.
K.1835 Physiological signal
amplifier2 A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physio logical
sources (e.g., the electroencephalogram).
K.1845 Physiological signal
conditioner2 A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals f or
recording and processing.
K.1855 Electroencephalogram
(EEG) telemetry system2 An electroe ncephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely
monitoring or measuring EEG signals by means of radio or telephone transmission systems.
K.1870 Evoked response electrical
stimulator2 An evok ed response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes
for the purpose of measuring the evoked response.
K.1880 Evoked response
mechanical stimulator2 An evoked response mechanical stim ulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for
the purpose of measuring a patient's evoked response.
K.1890 Evoked response photic
stimulator2 An evoked response photic stimulator is a device used to genera te and display a shifting pattern or to apply a brief light stimulus
to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.
K.1900 Evoked response auditory
stimulator2 An evoked response auditory stimulat or is a device that produces a sound stimulus for use in evoked response measurements or
electroencephalogram activation.
K.1935 Near infared (NIR) brain
hematoma detector2 A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near- infrared spectroscopy that is intended
to be used to evaluate suspected brain hematomas. Classification. Class 2.
K.1950 Tremor transducer 2 A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.
K.4030 Skull plate anvil 1 A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.
K.4060 Ventricular cannula 1 A ventricular cannula is a device used to puncture the ventricles of the brai n for aspiration or for injection. This device is frequently
referred to as a ventricular needle.K.4100 Ventricular catheter 2 A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material
from, the brain.
K.4125 Neurosurgical chair 1 A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.
K.4150 Scalp clip 2 A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.
K.4175 Aneurysm clip applier 2 An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.
K.4190 Clip forming/cutting
instrument1 A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock.
K.4200 Clip removal instrument 1 A clip removal instrument is a device used to remove surgical clips from the patient.
K.4250 Cryogenic surgical device 2 A cryogenic surgical device is a device u sed to destroy nervous tissue or produce lesions in nervous tissue by the application of
extreme cold to the selected site.
K.4275 Dowel cutting instrument 2 A dowel cutting instrument is a device used to cut dowels of bone for bone grafting.
K.4300 Manual cranial drills, burrs,
trephines, and their
accessories2 Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used withou t a power
source on a patient's skull.
K.4305 Powered compound cranial
drills, burrs, trephines, and
their accessories2 Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's
skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent
plunging of the tip into the brain.
K.4310 Powered simple cranial
drills, burrs, trephines, and
their accessories2 Powered simple cranial drills, burrs, trephines, and their accessories are bone c utting and drilling instruments used on a patient's
skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the
skull.
K.4325 Cranial drill handpiece
(brace )1 A cranial drill handpiec e (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting
tools that are used on a patient's skull.
K.4360 Electric cranial drill motor 2 An electric cranial drill motor is an electrically operated po wer source used with removable rotating surgical cutting tools or drill
bits on a patient's skull.
K.4370 Pneumatic cranial drill
motor2 A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cuttin g tools or
drill bits on a patient's skull.
K.4400 Radiofrequency lesion
generator2 A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct app lication
of radiofrequency currents to selected sites.
K.4460 Neurosurgical head holder
(skull clamp)2 A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position
during surgical procedures.K.4500 Cranioplasty material
forming instrument1 A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.
K.4525 Microsurgical instrument 1 A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.
K.4535 Nonpowered neurosurgical
instrument1 A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical
procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps,
gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
K.4545 Shunt system implantation
instrument1 A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes
tunneling instruments for passing shunt components under the skin.
K.4560 Stereotaxic instrument 2 A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes
or other devices within a patient's brain, spinal cord, or other part of the nervous system.
K.4600 Leukotome 1 A leukotome is a device used to cut sections out of the brain.
K.4650 Neurosurgical suture needle 1 A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
K.4700 Cottonoid paddie 2 A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
K.4725 Radiofrequency lesion
probe2 A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site
within the nervous system where a lesion is desired.
K.4750 Skull punch 1 A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flap s by wire
or other means.
K.4800 Self-retaining retractor for
neurosurgery2 A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.
K.4840 Manual rongeur 2 A manual rongeur is a manually operated instrument used for cutting or biting bone during s urgery involving the skull or spinal
column.
K.4845 Powered rongeur 2 A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.
K.4900 Skullplate screwdriver 1 A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws.
K.5030 Methyl methacrylate for
aneurysmorrhaphy2 Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-
curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or
obliteration by aneurysm clip.
K.5050 Biofeedback device 2 A biofeedback device is an instrument th at provides a visual or auditory signal corresponding to the status of one or more of a
patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the pat ient can
control voluntarily these physiological parameters.
K.5070 Bite block 2 A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.K.5150 Intravascular occluding
catheter3 An intravascular occluding catheter is a cat heter with an inflatable or detachable balloon tip that is used to block a blood vessel to
treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.
K.5175 Cartoid artery clamp 2 A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that
supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. T he
clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or
other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the
aneurysm or malformation.
K.5200 Aneurysm clip 2 An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it
from bleeding or bursting.
K.5225 Implanted malleable clip 2 An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an intracranial
blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissue or a mechanical device i n
place in a patient.
K.5235 Aversive conditioning
device2 An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patien t to
modify undesirable behavioral characteristics.
K.5250 Burr hole cover 2 A burr hole cove r is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial
bone removed during surgery.
K.5275 Nerve cuff 2 A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of
scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).
K.5300 Methyl methacrylate for
cranioplasty2 Methyl methacrylate for cranioplasty (skull repair) is a self-cur ing acrylic that a surgeon uses to repair a skull defect in a patient.
At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate s hape to
repair the defect.
K.5320 Preformed alterable
cranioplasty plate2 A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constru cted of a
material, e.g., tantalum that can be altered or reshaped at the time of surgery without changing the chem ical behavior of the
material.
K.5330 Preformed nonalterable
cranioplasty plate2 A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constr ucted of
a material, e.g., stainless steel or vi tallium that cannot be altered or reshaped at the time of surgery without changing the chemical
behavior of the material.
K.5360 Cranioplasty plate fastener 2 A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate
to the patient's skull to repair a skull defect.
K.5500 Lesion temperature monitor 2 A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is tobe made when a surgeon uses a radiofrequency (RF) lesion generator and probe.
K.5550 Central nervous system fluid
shunt and components2 A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the
central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracran ial
pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include c atheters, valved
catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a pati ent with
a shunt.
K.5600 Neurovascular mechanical
thrombectomy device for
acute ischemic stroke
treatment2 A neu rovascular mechanical thrombectomy device for acute ischemic stroke treatment is a device used in the treatment of acute
ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach ,
mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
K.5800 Cranial electrotheraphy
stimulator3 A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depres sion, or
anxiety.
K.5801 Computerized behavioral
therapy device for
psychiatric disorders2 A computerized behavioral therapy device for psychiatric disorders is a only device intended to provide a computerized versio n
of condition-specific behavioral the rapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric
conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to imp rove
recognized treatment outcomes.
K.5805 Repetitive transcranial
magnetic stimulation system2 A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magn etic
fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive
disorder.
K.5810 External functional
neuromuscular stimulator2 An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating mu scles in
the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.
K.5820 Implanted cerebellar
stimulator3 An implanted cerebellar stimulator is a device used to stimulate e lectrically a patient's cerebellar cortex for the treatment of
intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrod es
that are placed on the patient's cerebellum and an external trans mitter for transmitting the stimulating pulses across the patient's
skin to the implanted receiver.
K.5830 Implanted
diaphragmatic/phrenic nerve
stimulator3 An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulat ion of a patient's phrenic nerve
to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnorm ally
low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord i njury, or chronic lung disease. The
stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve and an extern al
transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
K.5840 Implanted 3 An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface a reas of aintracerebral/subcortical
stimulator for pain reliefpatient's brain to treat severe int ractable pain. The stimulator consists of an implanted receiver with electrodes that are placed
within a patient's brain and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted
receiver.
K.5850 Implanted spinal cord
stimulator for bladder
evacuation3 An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraple gic
patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the
intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus
medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's
skin to the implanted receiver.
K.5860 Implanted neuromuscular
stimulator3 An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femo ral nerve to
cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of a n
implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmit ting the
stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel
in the patient's shoe.
K.5870 Implanted peripheral nerve
stimulator for pain relief2 An implanted peripheral ne rve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a
patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a
peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted
receiver.
K.5880 Implanted spinal cord
stimulator for pain relief2,3 An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve
severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's sp inal cord
and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. Classification:
(1) Class 2 for devices intended to treat body/limbs cronical or intractable pain, (2) Class 3 for other devices (e.g., intended to treat
pain caused from failed back surgery syndrome).
K.5890 Transcutaneous electrical
nerve stimulator for pain
relief2 A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's
skin to treat pain.
K.5892 External vagal nerve
stimulator for headache2 An external vagal nerve stimulator for headache is a device used to apply an electrical current to a patient's vagus nerve th rough
electrodes placed on the skin for the treatment of headache.
K.5893 Thermal vestibular
stimulator for headache2 The thermal vestibular stimulator for headache is a device used to stimulate the vestibular system by applying thermal wavefo rms
through earpieces placed in a patient's ear canal for the treatment of headache.
K.5895 Vibratory counter-
stimulation device2 A vibratory counter- stimulation device is a device that provides electrically powered mechanical vibration to improve the quality
of sleep in patients with primary Restless Legs Syndrome.K.5896 Percutaneous nerve
stimulator for substance use
disorders2 A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the r eduction
of withdrawal symptoms associated with substance use disorders.
K.5897 External upper limb tremor
stimulator2 An external upper limb tremor stimulator is a device which is placed externally on the upper limb and designed to aid in trem or
symptom relief of the upper limb.
K.5900 Preformed craniosynostosis
strip2 A preformed craniosynostosis str ip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been
cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
K.5910 Dura substitute 2 A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
K.5940 Electroconvulsive therapy
device3 An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by
inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.
K.5950 Artificial embolization
device3 A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms
and cerebral ateriovenous malformations.
K.5960 Skull tongs for traction 2 Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation).
The device i s caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that
maintains, by traction, the patient's position.
K.5970 Cranial orthosis 2 A cranial orthosis is a device that is intended for medica l purposes to apply pressure to prominent regions of an infant's cranium
in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostoti c
positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
K.9999 Others(Neurological
Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
L.0001 Chorionic villus sampling
set3 The chorionic villus sampling set is a device used to obtain a sample of chorionic tissue through the cervix.
L.0002 Uterine manipulator/injector
cannula2 The uterine manipulator/injector cannula is a device to deliver cont rast media into the uterus and fallopian tubes for the evaluation
of the fallopian tubes and/or the uterus.
L.0004 Absorbable adhesion barrier 3 An absorbable adhesion barrier is used for patients undergoing open gynecologic surgery. This device is intend ed to reduce the
likelihood of developing postoperative adnexal adhesions either between abdominal wall and lower organs or between the uterus
and surrounding tissues in these patients.
L.1040 Viscometer for cervical
mucus1 A viscometer for cervical muc us is a device that is intended to measure the relative viscoelasticity of cervical mucus collected
from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a
female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.L.1050 Endocervical aspirator 2 An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of th e
cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to
detect malignant and premalignant lesions.
L.1060 Endometrial aspirator 2 An endometrial aspirator is a device designe d to remove materials from the endometrium (the mucosal lining of the uterus) by
suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).
L.1100 Endometrial brush 2 An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing
its surface. This device is used to study endometrial cytology (cells).
L.1175 Endometrial suction curette
and accessories2 An endometrial suction curette is a d evice used to remove material from the uterus and from the mucosal lining of the uterus by
scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type o f
device may include catheters, syringes, and tissue filters or traps.
L.1185 Endometrial washer 2 An endometrial washer is a device used to remove materials from the endometrium (the mucosal lining of the uterus) by washing
with water or saline solution and then aspirating with negative pressure. This device is used to study endometrial cytology (cells).
L.1300 Uterotubal carbon dioxide
insufflator and accessories2 An uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallop ian
tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.
L.1425 Perineometer 2 A perineometer is a device consisting of a fluid- filled sack for intravaginal use that is attached to an external manometer. The
devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles
and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.
L.1550 Amniotic fluid sampler
amniocentesis tray1 The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via
a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gaug e needle with stylet and a
30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc . The
device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormaliti es or anytime after 24 weeks
gestation when used to assess fetal maturity.
L.1560 Fetal blood sampler 2 A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal ski n with
a short blade and d rawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress
and fetal hypoxia.
L.1600 Transabdominal amnioscope
(fetoscope) and accessories3 A transabdominal amnioscope is a device designed to permit direct visual examination of the fetus by a telescopic system via
abdominal entry. The device is used to ascertain fetal abnormalities, to obtain fetal blood samples, or to obtain fetal tissu e. This
generic type of device may include the following accesso ries: trocar and cannula, instruments used through an operating channel
or through a separate cannula associated with the amnioscope, light source and cables, and component parts.
L.1630 Colposcope 2 A colposcope is a device designed to permit direct view ing of the tissues of the vagina and cervix by a telescopic system located
outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a lightsource, cables, and component parts.
L.1640 Culdoscope and accessories 1,2 Identification: A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopi c
system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical
procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an
operating channel, scope preheaters, light source and cables, and component parts. Classification:(1)Class 2 ;(2)Class 1 devices
for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, con nectors,
channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdo scope accessory instruments include:
lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature car rier/needle
holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and kn otting instrument, suture needle (without suture),
retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/ir rigation
probe.
L.1660 Transcervical endoscope
amnioscope and
accessories2 Atranscervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of an open tube
introduced into the uterus through the cervix. The device may be used to visualize the fetus or amniotic fluid and to sample fetal
blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, l ight
sources and cables, and component parts.
L.1690 Hysteroscope and
accessories1,2 Identification: A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic
system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than
sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope
preheaters, light sources and cables, and component parts. Classification: (1)Class 2 ;(2)Class 1 devices for hysteroscope
accessories that are not part of a specializ ed instrument or device delivery system; do not have adapters, connectors, channels, or
do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens
cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector,
mechanical (noninflatable), and scissors.
L.1700 Hysteroscopic insufflator 1,2 Identification: A hysteroscopic insufflator is a device designed to distend the uterus by filli ng the uterine cavity with a liquid or
gas to facilitate viewing with a hysteroscope. Classification: (1) Class 2 ;(2) Class 1 devices for tubing and tubing/filter fits which
only include accessory instruments that are not used to effect intrauterine acces s, e.g., hysteroscopic introducer sheaths, etc.; and
single-use tubing kits used for only intrauterine insufflation.
L.1710 Closed loop hysteroscopic
insufflator with cutter-
coagulator2 A closed loop hysteroscopic insufflator with cutter-coagulator is a device configured for hysteroscopic insufflation, resection, and
coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type con tains a
closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also
contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterin etissues.
L.1720 Gynecologic laparoscope
and accessories1,2 Identification: A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a
telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female
genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, s cope
preheater, light source and cables, and component parts. Classification: (1) Class 2 ;(2) Class 1 devices for gynecologic lap aroscope
accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels , or do
not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instru ments include:
the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature
carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle
(without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), sciss ors, and
suction/irrigation probe.
L.1730 Laparoscopic insufflator 1,2 A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend
it. Classification: (1) Class 2; (2) Class 1: Tubing and tubing/filter kits which include accessory instruments that are not used to
effect intra-abdominal insufflation (pneumoperitoneum).
L.2050 Obstetric data analyzer 3 An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtai ned from
fetal and maternal monitors. The obstetric data analyzer prov ides clinical diagnosis of fetal status and recommendations for labor
management and clinical interventions. This generic type of device may include signal analysis and display equipment, electro nic
interfaces for other equipment, and power supplies and component parts.
L.2225 Obstetric-gynecologic
ultrasonic imager2 An obstetric- gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female
patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or
of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: s ignal
analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and
component parts. This generic type of device does not include devices used to monitor the changes in some physiological condi tion
over long periods of time.
L.2600 Fetal cardiac monitor 2 A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to
separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated
during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type
of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of dev ice includes the
"fetal cardiotachometer (with sensors)" and the "fetal electrocardiographic monitor."
L.2620 Fetal
electroencephalographic3 A fetal electroencephalographic monitor is a device used to detect, measure, and record in graphic form ( by means of one or more
electrodes placed transcervically on the fetal scalp during labor) the rhythmically varying electrical skin potentials produc ed bymonitor the fetal brain.
L.2640 Fetal phonocardiographic
monitor and accessories2 A fetal phonocardiographi c monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic
form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following access ories:
signal analysis and display equipment, patient and equipment supports, and other component parts.
L.2660 Fetal ultrasonic monitor and
accessories2 A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually
by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characterist ic
in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible fo rm (e.g., use
of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and displa y
equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This gen eric type of
device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological
condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.
L.2675 Fetal scalp circular spiral
electrode and applicator2 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor an d delivery.
It establishes electrical contact between fetal skin and an e xternal monitoring device by a shallow subcutaneous puncture of fetal
scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular
electrodes.
L.2685 Fetal scalp clip electrode
and applicator3 A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin and an ex ternal
monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used to obtain a fet al electrocardiogram.
This generic type of device may include a clip electrode applicator.
L.2700 Intrauterine pressure
monitor and accessories2 An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid p ressure with a catheter
placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine
contractions during labor. This generic type of device may include the following accessories: signal analysi s and display
equipment, patient and equipment supports, and component parts.
L.2720 External uterine contraction
monitor and accessories2 An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of lab or. It measures
the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. Th is
generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.
L.2730 Home uterine activity
monitor2 A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions,
data transmission by telephone to a clinical setting, and for receipt and displ ay of the uterine contraction data at the clinic. The
HUAM system comprises a tocotransducer, an at- home recorder, a modem, and a computer and monitor that receive, process, and
display data. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.
L.2740 Perinatal monitoring system
and accessories2 A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal hear t rate
by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well- beingof the fetus during pregnancy, labor, and delivery. This generic type of device may include the following accessories: Centra l
monitoring system a nd remote repeaters, signal analysis and display equipment, patient and equipment supports, and component
parts.
L.2800 Computerized Labor
Monitoring System2 A computerized labor monitoring system is a system intended to continuously measure cervical dil ation and fetal head descent and
provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultra sound
transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of
measurements used to produce the display.
L.2900 Fetal stethoscope 1 A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds n ot only
through sound c hannels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use
ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.
L.2960 Obstetric ultrasonic
transducer and accessories2 An obstetric ultrasonic transducer is a device used to apply ultrasonic energy to, and to receive ultrasonic energy from, the body
in conjunction with an obstetric monitor or imager. The device converts el ectrical signals into ultrasonic energy, and vice versa,
by means of an assembly distinct from an ultrasonic generator. This generic type of device may include the following accessor ies:
coupling gel, preamplifiers, amplifiers, signal conditioners with the ir power supply, connecting cables, and component parts. This
generic type of device does not include devices used to generate the ultrasonic frequency electrical signals for application.
L.2980 Telethermographic system 1,3 A telethermographic system for diagnostic screening for detection of breast cancer or other uses is an electrically powered device
with a detector that is intended to measure, without touching the patient's skin, the self- emanating infrared radiation that reveals
the temperature variati ons of the surface of the body. This generic type of device may include signal analysis and display
equipment, patient and equipment supports, component parts, and accessories. Classification: (1) Class 1 devices intended for
adjunctive diagnostic screenin g for detection of breast cancer or other uses. (2)Class 3 devices for use alone in diagnostic screening
for detection of breast cancer or other use.
L.2982 Liquid crystal
thermographic system1,3 (a)A nonelectrically powered or an AC-powered liquid cryst al thermographic system intended for adjunctive use in diagnostic
screening for detection of breast cancer or other uses -(1)Identification. A nonelectrically powered or an AC- powered liquid crystal
thermographic system intended for use as an adjunct to ph ysical palpation or mammography in diagnostic screening for detection
of breast cancer or other uses is a nonelectrically powered or an AC- powered device applied to the skin that displays the color
patterns of heat sensitive cholesteric liquid crystals tha t respond to temperature variations of the surface of the body. This generic
type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and t he
liquid crystals, component parts, and accessories. (2) Classification. Class 1.
(b) Anonelectrically powered or an AC- powered liquid crystal thermographic system intended for use alone in diagnostic screening
for detection of breast cancer or other uses-(1) Identification: A nonelectrically powered or an AC- powered liquid crystal
thermographic system intended for use as the sole diagnostic screening tool for detection of breast cancer or other uses is anonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric
liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include im age
display and recording equipment, patient and equipment supports, a means to ensure thermal contact between the patient's skin
and the liquid crystals, component parts, and accessories. (2) Classification: Class 3.
L.3200 Cervical drain 2 A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.
L.3575 Vaginal pessary 2 A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as
uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.
L.3650 Fallopian tube prosthesis 2 A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after
reconstructive surgery.
L.3900 Vaginal stent 2 A vaginal stent is a d evice used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after
reconstructive surgery.
L.4050 Gynecologic laparoscopic
power morcellation
containment system2 A gynecologic laparoscopic power morcellation containme nt system is a device consisting of an instrument port and tissue
containment method that creates a working space allowing for direct visualization during a power morcellation procedure
following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.
L.4100 Endoscopic electrocautery
and accessories2 An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is designed to
coagulate fallopian tube tissue with a probe heated by low- voltage energy. This generic type of device may include the following
accessories: electrical generators, probes, and electrical cables.
L.4120 Gynecologic electrocautery
and accessories2 A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically
heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observ ation. This
generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.
L.4150 Bipolar endoscopic
coagulator-cutter and
accessories2 A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under
endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through ti ssue
between two electrical contacts of a probe. This generic type of device may include the follo wing accessories: an electrical
generator, probes, and electrical cables.
L.4160 Unipolar endoscopic
coagulator-cutter and
accessories2 A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a h igh frequency
electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization an d in
other operative procedures under endoscopic observation. This generic type of device may include the following a ccessories: an
electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not inclu de devices
used to perform female sterilization under hysteroscopic observation.
L.4250 Expandable cervical dilator 3 An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch ope n)
the cervical os.L.4260 Hygroscopic Laminaria
cervical dilator2 A hygroscopic laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os. This device shall expand to
several times its original diameter by absorbing water from the cervix over a few hours (usually less than 24 hours). This de vice
contains hygroscopic laminaria and synthetic moisture-absorbing materials.
L.4270 Vibratory cervical dilators 3 A vibratory cervical dilator is a device designed to dilate the cervical os by stretching it with a power- driven vibrating probe head.
The device is used to gain access to the uterus or to induce abortion, but is not to be used during labor when a viable fetus is desired
or anticipated.
L.4340 Fetal vacuum extractor 2 A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in t he
birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type o f
device may include the cup, hosing, vacuum source, and vacuum control.
L.4350 Fetal head elevator 2 A fetal head elevator is a device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean
section.
L.4400 Obstetric forceps 2 An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in
the birth passage and facilitate delivery.
L.4500 Obstetric fetal destructive
instrument2 An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or
anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.
L.4520 Obstetric-gynecologic
general manual instrument1 An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic
manipulative functions. This generic type of device consists of the following:(1) An episiotomy scissors is a cutting instrum ent,
with two opposed shearing blades, used for surgical incision of the vulvar o rifice for obstetrical purposes.(2) A fiberoptic metal
vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.(3) A metal
vaginal speculum is a metal instrument used to expose the interior of the vagina.(4) An umbilical scissors is a cutting instrument,
with two opposed shearing blades, used to cut the umbilical cord.(5) A uterine clamp is an instrument used to hold the uterus by
compression.(6) A uterine packer is an instrument used to introd uce dressing into the uterus or vagina.(7) A vaginal applicator is
an instrument used to insert medication into the vagina.(8) A vaginal retractor is an instrument used to maintain vaginal exp osure
by separating the edges of the vagina and holding back the tissue.(9) A gynecological fibroid hook is an instrument used to exert
traction upon a fibroid.(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.
L.4530 Obstetric-gynecologic
specialized manual
instrument1,2 (a)An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric- gynecologic
procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping),
where struct ural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An
amniotome is an instrument used to rupture the fetal membranes.(2) A circumcision clamp is an instrument used to compress
the foreskin of the penis during circumcision of a male infant.(3) An umbilical clamp is an instrument used to compress the
umbilical cord.(4) A uterine curette is an instrument used to scrape and remove material from the uterus.(5) A fixed- sizecervical dilator is any of a s eries of bougies of various sizes used to dilate the cervical os by stretching the cervix.(6) A uterine
elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.(7) A gynecological surgical forcep s is
an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.(8) A cervical
cone knife is a cutting instrument used to excise and remove tissue from the cervix.(9) A gynecological cerclage needle is a
looplike instrument used to suture the cervix.(10) A hook- type contraceptive intrauterine device (IUD) remover is an
instrument used to remove an IUD from the uterus.(11) A gynecological fibroid screw is an instrument used to hold onto a
fibroid.(12) A uterine sound is an instrument us ed to determine the depth of the uterus by inserting it into the uterine cavity.(13)
A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the
cervix or vagina.(14) A gynecological biopsy fo rceps is an instrument with two blades and handles used for gynecological
biopsy procedures.(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.(16) An
internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.(17) A nonmetal
vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.(18) A fiberoptic nonmetal vaginal
speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)Classification: (1) Class 2 ;(2) Class 1 devices for the amniotome, uterine curette, cervical dilator (fixed- size bougies), cerclage
needle, IUD remover, uterine sound, and gynecological biopsy forceps.
L.4550 Gynecologic surgical laser 2 A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tiss ue by
radiant light energy. The device is used only in conjunction with a colposcope as part of a gyne cological surgical system. A
colposcope is a magnifying lens system used to examine the vagina and cervix.
L.4900 Obstetric table and
accessories2 An obstetric table is a device with adjustable sections designed to support a patient in the various positi ons required during obstetric
and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support
attachments, and cabinets for warming instruments and disposing of wastes.
L.5050 Metreurynter-balloon
abortion system3 A metreurynter- balloon abortion system is a device used to induce abortion. The device is inserted into the uterine cavity, inflated,
and slowly extracted. The extraction of the balloon from the uterus causes dilation of the cervical os. This generic type of device
may include pressure sources and pressure controls.
L.5070 Vacuum abortion system 2 A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the
uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation.
This type of device may include aspiration cannula, vacuum source, and vacuum controller.
L.5100 Obstetric anesthesia set 2 An obstetric anesthe sia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended
for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pude ndal)
that may be used during labor, delivery, or both.
L.5200 Hemorrhoid prevention 2 A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery proce ss.pressure wedge External mechanical support of the periana l region is intended to help prevent the occurrence of external hemorrhoids associated
with vaginal childbirth. Classification. Class 2.
L.5210 Pressure wedge for the
reduction of cesarean
delivery2 A pressure wedge for the reduction of cesarean delivery is a device that provides external mechanical support to the perianal region
during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the
occurrence of cesarean delivery.
L.5225 Abdominal decompression
chamber3 An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the
relief of abdominal pain during pregnancy or labor.
L.5250 Cervical cap 2 A cervical cap is a flexible cupl ike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination.
This generic type of device is not for contraceptive use.
L.5300 Condom 2 A condom is a sheath which completely covers the penis with a closely fitting m embrane. The condom is used for contraceptive
and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to co llect
semen to aid in the diagnosis of infertility. The device may contain lubricants compatible for use with condoms.
L.5310 Condom with spermicidal
lubricant2 A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubr icant
that contains a spermicidal agent, Nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing
sexually-transmitted diseases).
L.5320 Glans sheath 3 A glans sheath device is a sheath which covers only the glans penis or part thereof and may also cover the area in the immed iate
proximity thereof, the corona and frenulum, but not the entire shaft of the penis. It is indicated only for the prevention of pregnancy
and not for the prevention of sexually-transmitted diseases.
L.5330 Multiple-use female
condom3 A multiple-use female condom is a sheath- like device that lines the vaginal wall and is inserted into the vagina prior to the initiation
of coitus. At the conclusion of coitus, the device can be reused. It is indicated for contraception and prophylactic (prevent ing the
transmission of sexually transmitted infections) purposes.
L.5340 Single-use internal condom 2 A single-use internal condom is an over-the-counter sheath- like device that lines the vaginal or anal wall and is inserted into the
vagina or anus prior to the ini tiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for
contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes.
L.5350 Contraceptive diaphragm
and accessories2 A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posteri or
vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of
device may include an introducer.
L.5360 Contraceptive intrauterine
device (IUD) and introducer3 A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fun dus
with a string extending fro m the device through the cervical os into the vagina. This generic type of device includes the introducer,
but does not include contraceptive IUD's that function by drug activity.L.5380 Contraceptive tubal
occlusion device (TOD) and
introducer3 A contra ceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical
structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used t o prevent
pregnancy.
L.5390 Perineal heater 2 A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surface of the
perineum (the area between the vulva and the anus) and is used to soothe or to help heal t he perineum after an episiotomy (incision
of the vulvar orifice for obstetrical purposes).
L.5400 Menstrual cup 2 A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
L.5460 Scented or scented
deodorized menstrual
tampon2 A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inse rted
into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for ae sthetic
purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of
device does not include menstrual tampons treated with added antimicrobial agents or other drugs.
L.5470 Unscented menstrual
tampon2 An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the v agina
and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual ta mpons treated
with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
L.5900 Therapeutic vaginal douche
apparatus1,2 Identification: A therapeutic vaginal douche apparatus is a device that is a bag or bottle with t ubing and a nozzle. The apparatus
does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions excep t it
is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to
direct a stream of solution into the vaginal cavity. Classification:(1) Class 2 ;(2) Class 1 devices operated by gravity.
L.5920 Vaginal insufflator 1 A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand- held bulb into the vagina
through an open speculum.
L.5940 Powered vaginal muscle
stimulator for therapeutic
use3 A powered vaginal muscle stimulator is an electrically powered device designed to stimulate directly the muscles of the vagina
with pulsating electrical current. This device is intended and labeled for therapeutic use in increasing muscular tone and st rength
in the treatment of sexual dysfunction. This generic type of device does not include devices used to treat urinary incontinence.
L.5960 Genital vibrator for
therapeutic use2 A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the tre atment of
sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).
L.5970 Clitoral engorgement device 2 A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexua l
arousal disorder.
L.5980 Surgical mesh for
transvaginal pelvic organ
prolapse repair3 Surgical mesh for transvaginal pelvic organ prolapse repair is a device intended to reinforce soft tissue in the pelvic floor . This
device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-
synthetic materials.L.6100 Assisted reproduction
needles2 Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian tr ansfer (GIFT), or other
assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo( s)
into the body. This generic type of device may include a single or double lumen needle and component par ts, including needle
guides, such as those used with ultrasound.
L.6110 Assisted reproduction
catheters2 Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or o ther
assisted reproducti on procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body.
This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.
L.6120 Assisted reproduction
accessories2 Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with as sisted
reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or mai ntain temperature. This generic
type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of e ggs
(ova).(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate sm all volumes of fluid during assisted
reproduction procedures.(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near
body temperature. A dish/plate/microscope stage warmer is a device used to maintain the t emperature of the egg (oocyte) during
manipulation.(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.(5)
Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or e mbryos at an appropriate
freezing temperature.
L.6130 Assisted reproduction
microtools2 Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or tr ansfer
human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
L.6140 Assisted reproduction
micropipette fabrication
instruments2 Assisted reproduction micropipette fabrication devices are instruments intended to pull, bev el, or forge a micropipette or needle
for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.
L.6150 Assisted reproduction
micromanipulators and
microinjectors2 Assisted reproduction mi cromanipulators are devices intended to control the position of an assisted reproduction microtool.
Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assiste d
reproduction microtool.
L.6160 Assisted reproduction
labware2 Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfe r
human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIF T), or other assisted reproduction
procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and o ther vessels
that come into physical contact with gametes, embryos or tissue culture media.
L.6165 Intravaginal culture system 2 An intravaginal culture system is a device intended for preparing, holding, and transferring human gametes or embryos during
intravaginal in vitro fertilization or intravaginal culture procedures.
L.6170 Assisted reproduction water 2 Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen- freeand water purification
systemswater for reconstitution of media used for aspiration, incubation, transfer or st orage of gametes or embryos for in vitro fertilization
(IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other a ssisted
reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution
available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage
of gametes or embryos for IVF or other assisted reproduction procedures.
L.6180 Reproductive media and
supplements2 Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and
powder versions of various substances that come in direct physical contac t with human gametes or embryos (including water, acid
solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media)
for the purposes of preparation, maintenance, transfer or storage. Su pplements are specific reagents added to media to enhance
specific properties of the media (e.g., proteins, sera, antibiotics, etc.).
L.6190 Assisted reproductive
microscopes and
microscope accessories1 Assisted reproduction microscopes and microscope ac cessories (excluding microscope stage warmers, which are classified under
assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of micros copes
and accessories used for these purposes would inclu de phase contrast microscopes, dissecting microscopes and inverted stage
microscopes.
L.6195 Assisted Reproduction
Embryo Image Assessment
System2 An Assisted Reproduction Embryo Image Assessment System is a device that is designed to obtain and analyze light microscopy
images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there a re
multiple embryos deemed suitable for transfer or freezing.
L.6200 Assisted reproduction laser
system2 The ass isted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam
used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assiste d
reproduction procedures.
L.9999 Others(Obstetrical and
Gynecological Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
M.0001 Ophthalmic excimer laser
system3 Ophthalmic excimer laser system is intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic
procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a lig ht source,
controls/foot-switch, monitoring system, and probes. This system commonly connects to a slit lamp or non- contact
ophthalmoscope by an optical fiber.
M.0002 Endocapsular ring 3 An endocapsular ring is an ophthalmic device for placement into th e capsular bag. It may be used for the stabilization of lens
capsular bag when zonules are broken or missing. Examples are capsular tension rings.
M.0003 Lacrimal Punctum Plug 2 A lacrimal punctum plug is an ophthalmological device designed to be inserted through the punctal opening into the canaliculus
in order to block tear drainage through the lacrimal drainage system.
M.1040 Ocular esthesiometer 1 An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.M.1050 Adaptometer
(biophotometer)1 An adaptometer (biophotometer) is an AC- powered device that provides a stimulating light source which has various controlled
intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light
threshold.
M.1070 Anomaloscope 1 An anomaloscope is an AC- powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be
matched by the patient.
M.1090 Haidinger brush 1 A Haidinger brush is an AC-powered device that provides two conical brus- hlike images with apexes touching which are viewed
by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuri ng macular
integrity.
M.1100 Retinopathy detection
software device2 A retinopathy detection software device is a software device that incorporates algorithms to evaluate ophthalmic images for
diagnostic screening to identify retinal diseases or conditions.
M.1120 Ophthalmic camera 2 An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
M.1140 Ophthalmic chair 1 An ophthalmic chair is an AC-powered or manual device with adjustable positioning in w hich a patient is to sit or recline during
ophthalmological examination or treatment.
M.1160 Color vision plate
illuminator1 A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plat es.
It may include a filter.
M.1200 Optokinetic drum 1 An optokinetic drum is a drum- like device covered with alternating white and dark stripes or pictures that can be rotated on its
handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.
M.1220 Corneal electrode 2 A corneal electrode is an AC- powered device, usually part of a special contact lens, intended to be applied directly to the cornea
to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).
M.1250 Euthyscope 1,2 A euthyscope is a device that is a modified AC-powered or battery- powered ophthalmoscope (a perforated mirror device intended
to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye.
The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae w here
only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of
vision without apparent disease of the eye). Classification: (1) Class 1 for the battery-powered device. Class 2 for the AC- powered
device.
M.1270 Exophthalmometer 1 An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal
protrusion of the eyeball).
M.1290 Ophthalmic Fixation device 1 A fixation device is an AC-powered device intende d for use as a fixation target for the patient during ophthalmological
examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the cen ter of the
macular retina of the eye.)M.1300 Afterimage flasher 2 An afterimage flasher is an AC- powered light that automatically switches on and off to allow performance of an afterimage test in
which the patient indicates the positions of afterimages after the light is off. The device is intended to determine
harmonious/anomalous retinal correspondence (the condition in which corresponding points on the retina have the same direction al
value).
M.1320 Fornixscope 1 A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.
M.1340 Haploscope 1 A haploscope is an AC-powered device that consists of two movable viewing tubes, each containing a slide carrier, a low- intensity
light source for the illumination of the slides, and a high-intensity light source for crea ting afterimages. The device is intended to
measure strabismus (eye muscle imbalance), to assess binocular vision (use of both eyes to see), and to treat suppression and
amblyopia (dimness of vision without any apparent disease of the eye).
M.1342 Strabismus detection device 2 A strabismus detection device is a device designed to simultaneously illuminate both eyes with polarized light for automated
detection of strabismus by analyzing foveal birefringence properties.
M.1350 Keratoscope 1 A keratoscope is an AC-powered or battery- powered device intended to measure and evaluate the corneal curvature of the eye.
Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the
photokeratoscope which records corneal curvature by taking photographs of the cornea.
M.1360 Visual field laser instrument 2 A visual field laser instrument is an AC- powered device intended to provide visible laser radiation that produces an interference
pattern on the retina to evaluate retinal function.
M.1375 Bagolini lens 1 A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visu alization
of objects. The device is placed in a trial frame and intended to deter mine harmonious/anomalous retinal correspondence (a
condition in which corresponding points on the retina have the same directional values).
M.1380 Diagnostic condensing lens 1 A diagnostic condensing lens is a device used in binocular indirect ophthalmos copy (a procedure that produces an inverted or
reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.
M.1385 Polymethylmethacrylate
(PMMA) diagnostic contact
lens2 A polymethylmethacrylate (PMMA) diagnos tic contact lens is a device that is a curved shell of PMMA intended to be applied for
a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
M.1390 Flexible diagnostic Fresnel
lens1 A fle xible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly
refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients with aphakia (absence of the
lens of the eye).
M.1395 Diagnostic Hruby fundus
lens1 A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and
the fundus of the eye under slitlamp illumination and magnification.
M.1400 Maddox lens 1 A Maddox lens is a device that is a series of red cylinders that change the size, shape, and color of an image. The device is intendedto be handheld or placed in a trial frame to evaluate eye muscle dysfunction.
M.1405 Ophthalmic trial lens set 1 An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or insert ed in a
trial frame for vision testing to determine refraction.
M.1410 Ophthalmic trial lens clip 1 An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for
vision testing.
M.1435 Maxwell spot 1 A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
M.1450 Corneal radius measuring
device1 A corneal radius measuring device is an ophthalmic device that is intended to measure corneal curvature. This device measures
corneal curvature through projecting the corneal image to handheld eyepiece or magnifying glass. The item does not include
keratometer.
M.1460 Stereopsis measuring
instrument1 A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on diffe rent
planes.
M.1510 Eye movement monitor 2 An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
M.1570 Ophthalmoscope 2 An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine
the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
M.1605 Perimeter 1 A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patien t. The
device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
M.1630 AC-powered
photostimulator2 An AC-powered photostimulator is an AC-powered device intended to provide light stimulus wh ich allows measurement of retinal
or visual function by perceptual or electrical methods (e.g., stroboscope).
M.1640 Ophthalmic preamplifier 2 An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals fro m the eye in
electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooc ulography
(testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyebal l), and electromyography
(recording electrical currents generated in active muscle).
M.1650 Ophthalmic bar prism 1 An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to meas ure
latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.
M.1655 Ophthalmic Fresnel prism 1 An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a
prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.
M.1660 Gonioscopic prism 1 A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device ma y
have angled mirrors to facilitate visualization of anatomical features.
M.1665 Ophthalmic rotary prism 1 An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular devia tion
in patients with latent or manifest strabismus (eye muscle deviation).M.1670 Ophthalmic isotope uptake
probe2 An ophthalmic isotope uptake probe is an AC- powered device intended to measure, by a probe which is placed in close proximity
to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.
M.1680 Ophthalmic projector 1 An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.
M.1690 Pupillograph 1 A pupillograph is an AC- powered device intended to measure the pupil of the eye by reflected light and record the responses of
the pupil.
M.1700 Pupillometer 1 A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of
the eye.
M.1750 Skiascopic rack 1 A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended a s an aid
in refraction.
M.1760 Ophthalmic refractometer 1 An ophthalmic refractometer is an automatic AC- powered device that consists of a fixation system, a measurement and recording
system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
M.1770 Manual refractor 1 A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
M.1780 Retinoscope 1,2 A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the e ye by illuminating the retina
and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent ray s.
Classification: (1) Class 1 for the DC-powered device. (2) Class 2 for the AC-powered device.
M.1790 Nearpoint ruler 1 A nearpoint ruler is a device calibrated in centimeters intended to measure the nearpoint of convergence (the point to which the
visual lines are directed when convergence is at its maximum).
M.1800 Schirmer strip 1 A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to
stimulate and evaluate formation of tears.
M.1810 Tangent screen
(campimeter)1 A tangent screen (campimeter) is an AC-powered or battery-powere d device that is a large square cloth chart with a central mark
of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes
projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
M.1850 AC-powered slitlamp
biomicroscope2 An AC-powered slitlamp biomicroscope is an AC- powered device that is a microscope intended for use in eye examination that
projects into a patient's eye through a control diaphragm a thin, intense beam of light.
M.1870 Stereoscope 1 A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-
dimensional appearance of solidity and relief. It is inte nded to measure the angle of strabismus (eye muscle deviation), evaluate
binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.
M.1905 Nystagmus tape 1 Nystagmus tape is a device that is a long, narrow str ip of fabric or other flexible material on which a series of objects are printed.
The device is intended to be moved across a patient's field of vision to elicit optokinetic nystagmus (abnormal and irregular eye
movements) and to test for blindness.M.1910 Spectacle dissociation test
system1 A spectacle dissociation test system is an AC-powered or battery- powered device, such as a Lancaster test system, that consists of
a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.
M.1925 Diurnal pattern recorder
system2 A diurnal pattern recorder system is a nonimplantable, device incorporating a telemetric sensor to detect changes in ocular
dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
M.1930 Tonometer and accessories 2 A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the glob e
of the eye and measuring the amount of indentation prod uced (Schiotz type) or to measure intraocular tension by applanation
(applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph reco rding
system. The device is intended for use in the diagnosis of glaucoma.
M.1945 Transilluminator 1,2 A transilluminator is an AC-powered or battery- powered device that is a light source intended to transmit light through tissues to
aid examination of patients. Classification: (1) Class 1 battery-powered device. (2) Class 2 AC-powered device.
M.3100 Ophthalmic tantalum clip 2 An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring toget her
the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
M.3130 Ophthalmic conformer 1 An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball an d
eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
M.3200 Artificial eye 1 An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be in serted in
a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended
to be implanted.
M.3300 Absorbable implant (scleral
buckling method)2 An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
M.3320 Eye sphere implant 2 An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the conten ts
of the eyeball with the sclera left intact.
M.3340 Extraocular orbital implant 2 An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or buil ding
up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
M.3400 Keratoprosthesis 2 A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraope ratively
or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
M.3600 Intraocular lens 3 An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural le ns of an
eye.
M.3800 Scleral shell 1 A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-
cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended
to be implanted.M.3920 Eye valve implant 2 Eye valve implant is an implantable one- way pressure sensitive valve intended to reduce intraocular pressure in the anterior
chamber of the eye. This device is for patients with glaucoma.
M.4070 Powered corneal burr 1 A powered corneal burr is an AC-powered or battery- powered device that is a motor and drilling tool intended to remove rust rings
from the cornea of the eye.
M.4100 Radiofrequency
electrosurgical cautery
apparatus2 A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powe red device intended for use during ocular
surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
M.4115 Thermal cautery unit 2 A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular s urgery to coagulate tissue or
arrest bleeding by heat conducted through a wire tip.
M.4150 Vitreous aspiration and
cutting instrument2 A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to r emove
vitreous matter from the vitreous cavity or remove a crystalline lens.
M.4155 Scleral plug 2 A scleral plug is a device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedur e.
These plugs prevent intraocu lar fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head
portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision.
Scleral plugs are removed before completing the surgery.
M.4170 Cryophthalmic unit 2 A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a
refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice
ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.
M.4250 Ophthalmic electrolysis unit 1,2 An ophthalmic electrolysis unit is an AC-powered or battery- powered device intended to destroy ocular hair follicles by applying
a galvanic electrical current. Classification: (1) Class 1 battery-powered device. (2) Class 2 AC-powered device.
M.4270 Intraocular gas 3 An intraocular gas is a devic e consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached
retina.
M.4275 Intraocular fluid 3 An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid perfo rmance of
surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or funct ion as a
tamponade during retinal reattachment.
M.4280 Intraocular pressure
measuring device3 An intraocular pressure measuring device is a manual or AC- powered device intended to measure intraocular pressure. Also
included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include
calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.
M.4300 Intraocular lens guide 1 An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intra ocular
lens and be removed after insertion is completed.M.4335 Operating headlamp 1,2 An operating headlamp is an AC-powered or battery- powered device intended to be worn on the user's head to provide a light
source to aid visualization during surgical, diagnostic, or therapeutic procedures. Classification: (1) Class 1 battery- powered
device. (2) Class 2 AC-powered device.
M.4350 Manual ophthalmic surgical
instrument1 A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical
procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp,
ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal
dilator, eriso phake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing
needle, lachrymal probe, trabeculotomy probe, cornea- sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal
sac rongeur, opht halmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud,
trabeculotome or ophthalmic manual trephine.
M.4360 Ocular surgery irrigation
device1 An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver
continuous, controlled irrigation to the surgical field.
M.4370 Keratome 1 A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial
thickness) transplant.
M.4390 Ophthalmic laser 2 An ophthalmic laser is an AC- powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser
beam.
M.4392 Nd:YAG laser for posterior
capsulotomy2 The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q- switched solid state
Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates s hort
pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high
irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the in visible
Nd:YAG laser radiation on or in close proximity to the target tissue.
M.4400 Electronic metal locator 2 An electronic metal locator is an AC- powered device with probes intended to locate metallic foreign bodies in the eye or eye
socket.
M.4570 Ophthalmic surgical marker 1 An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scler al
surgical manipulation.
M.4610 Ocular pressure applicator 2 An ocular pressure applicator is a manual device that consists of a sphygmomanometer- type squeeze bulb, a dial indicator, a band,
and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.
M.4670 Phacofragmentation system 2 A phacofragmentation system is an AC-powered devic e with a fragmenting needle intended for use in cataract surgery to disrupt
a cataract with ultrasound and extract the cataract.
M.4690 Ophthalmic photocoagulator 2 An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an e xtended noncoherent light source
to occlude blood vessels of the retina, choroid, or iris.M.4750 Ophthalmic eye shield 1 An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended for protection during eye surgery,
injury, disease or retain dressing materials in place.
M.4770 Ophthalmic operating
spectacles (loupes)1 Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a
surgeon to magnify the surgical site during ophthalmic surgery.
M.4790 Ophthalmic sponge 2 An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other
material intended to absorb fluids from the operative field in ophthalmic surgery.
M.5100 Ophthalmic beta radiation
source2 An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
M.5200 Eyelid thermal pulsation
system2 An eyelid thermal pulsation system is an electrically- powered device intended for use in the application of localized heat and
pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, includin g
meibomian gland dysfunctio n (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a
component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.
M.5300 Tear electrostimulation
device2 A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.
M.5310 Intranasal electrostimulation
device for dry eye
symptoms2 An intranasal electrostimulation device for dry eye symptoms is a non- implantable, electrostimulation device intended to increase
tear production for improvement in dry eye symptoms.
M.5350 Ultrasound cyclodestructive
device2 Ultrasound cyclodestructive device is a device that reduces the intraocular pressure by g enerating a series of lesions caused by
high- intensity focused ultrasound (HIFU) energy in the ciliary body and trabecular meshwork. This device is designed to treat
refractory glaucoma.
M.5600 Ptosis crutch 1 A ptosis crutch is a device intended to be mo unted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a
result of faulty development or paralysis) to hold the upper eyelid open.
M.5700 Eyelid weight 2 An eyelid weight is a device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape
and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete
eyelid closure)( Lagophthalmos).
(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
M.5844 Corrective spectacle lens 1,2 A corrective spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to
provide refractive corrections. The device may be modified to protect the eyes from bright sunlight (i.e., corrective sunglasses).
Corrective sunglass lenses may be reflective, tinted, polarizing, or photosensitized. Products made with this corrective spectacle
lens include corrective and protective sports goggles, such as swimmers’ goggles, ski goggles, racquetball eye guards, and diving
goggles.Classification: (1) Class1 (2) Class 2 devices are intended to have the ability to regulate eyeball growth, thereby delaying the
progression of myopia or reducing myopia in children.
M.5905 Oral electronic vision aid 2 An oral electronic vision aid is a battery-powered device that contains an electrode stimulation array to generate ele ctrotactile
stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients
in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide
dog.
M.5916 Rigid gas permeable contact
lens2,3 A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision c onditions.
The device is made of various materials, such as cellulose acetate butyrate, polyacrylate- silicone, or silicone elastomers, whose
main polymer molecules generally do not absorb or attract water. Class 2 if the device is intended for daily wear only. Class 3 if
the device is intended for extended wear.
M.5918 Rigid gas permeable contact
lens care products1,2 A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing,
lubricating/rewetting, or storing of a rigid gas permeable contact lens. This in cludes all solutions and tablets used together with
rigid gas permeable contact lenses. Classification: (1) Class 1 contact lens container. ;(2) Class 2 other devices.
M.5925 Soft (hydrophilic) contact
lens2,3 A soft (hydrophilic) contact lens is a devic e intended to be worn directly against the cornea and adjacent limbal and scleral areas
of the eye to correct vision conditions, act as a therapeutic bandage .The device is made of various polymer materials the ma in
polymer molecules of which absorb or att ract a certain volume (percentage) of water. Class 2 if the device is intended for daily
wear only. Class 3 if the device is intended for extended wear. The item includes plain soft (hydrophilic) contact lens.
M.5928 Soft (hydrophilic) contact
lens care products1,2 A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting,
lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together w ith soft
(hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
Classification: (1) Class 1 contact lens container. ;(2)Class 2 other devices.
M.9999 Others(Ophthalmic Devices) 1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
N.0001 Orthopedic extracorporeal
shock wave system3 An orthopedic extracorporeal shock wave therapy system is a therapy system for orthopedic diseases.
N.0003 Intraarticular hyaluronic
acid implants3 Intra-articular hyaluronic acid implants are hyaluronic acid used for intra-articular injections.
N.0004 Inflatable bone expander
system2 An inflatable bone expander system is used to expand the vertebral body to form a cavity during vertebroplasty, so as to inject
bone cement to restore and stabilize the vertebral body and can also be used for forming pores inside the cancellous bone of spine,
hand, tibia, radius and calcaneus.
N.0005 Intervertebral disc 3 Intervertebral disc prosthesis is a disc non-fusion implantable device used in intervertebral disc replacement surgery in cervicalprosthesis spine and lumbar spine which can retain the height of the interv ertebral disc and maintain the activity in the affected segment.
Intervertebral disc prosthesis may include but not limited to the following formats : Composite, constructed by multipal
components, which is generally formed by two independent end plate and a gasket ; Elastic, for med by two end plates and elastic
polymer core (the core is elastic which aims to mimic the elasticity of the intervertebral disc) ; Mechanical, formed by two joint
componets with same material in general.
N.1100 Arthroscope 1,2 Anarthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and
accessories also is intended to perform surgery within a joint. Classification: (1) Class 1 for the following manual arthrosc opic
instrum ents: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps,
retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. (2) Class 2 other devices.
N.1240 AC-powered dynamometer 2 An AC-powered dynamometer is an AC- powered device intended for medical purposes to assess neuromuscular function or degree
of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-
strength of a patient's hand.
N.1250 Nonpowered dynamometer 1 A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength
of a patient's hand.
N.1500 Goniometer 1,2 Identification: A goniometer is an AC- powered or battery powered device intended to evaluate joint function by measuring and
recording ranges of motion, acceleration, or forces exerted by a joint. Classification: (1) Class 1 devices that does not use electrode
lead wires and patient cables. ;(2) Class 2 devices that uses electrode lead wires and patient cables.
N.1520 Nonpowered goniometer 1 A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
N.3000 Bone cap 1 A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra- high molecular
weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth
in juvenile amputees.
N.3010 Bone fixation cerclage 2 A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium- molybdenum, and
that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the
bone with wire or screws, and used in the fixation of fractures.
N.3015 Bone heterograft 3 Bone heterograft is a device intended to be implanted that is made from mature (adul t) bovine bones and used to replace human
bone following surgery in the cervical region of the spinal column.
N.3020 Intramedullary fixation rod 2 An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-
molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
N.3023 In vivo cured intramedullary
fixation rod2 An in vivo cured intramedullary fixation rod is a i mplanted device consisting of a balloon that is inserted into the medullary canal
of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is
exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.N.3025 Passive tendon prosthesis 2 A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade
silicone elastomer inte nded for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a
period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to functi on
as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.
N.3027 Polymethylmethacrylate
(PMMA) bone cement2 Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate,
polymethy lmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The
device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or meta llic
prosthetic implants to living bone.
N.3030 Single/multiple component
metallic bone fixation
appliance and accessories2 Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting o f
one or more metallic c omponents and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate
combination that are made of alloys, such as cobalt-chromium- molybdenum, stainless steel, and titanium, that are intended to be
held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures
of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condy lar
fractu res of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted
or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
N.3040 Smooth or threaded metallic
bone fixation fastener2 A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segme nt or
rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or
partially threaded, straight or U- shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end.
It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin fo r insertion of other implants, or it may be
implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
N.3045 Resorbable calcium salt
bone void filler device2,3 A resorbable calcium salt bone void filler device i s a resorbable implant intended to fill bony voids or gaps of the extremities,
spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. Classifi cation: (1)
Class 2 devices do not contain medicine. (2) Class 3 devices contain medicine.
N.3050 Spinal interlaminal fixation
orthosis2 A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists
of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent
vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device i s used
primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or
dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
N.3060 Spinal intervertebral body
fixation orthosis2 A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral
plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserte d in a hole in the center of each of the
plates. A braided cable is threaded through each eye- type screw. The cable is tightened with a tension device and it is fastened orcrimped at each eye-type screw. The device is used to apply force to a series of ve rtebrae to correct "sway back," scoliosis (lateral
curvature of the spine), or other conditions.
N.3070 Pedicle screw spinal system 2 Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 3 16L
stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al- 4V , and unalloyed titanium, that allow the surgeon
to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists
of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleev es,
or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. This device is a
rigid or semi-regid fixation system and intended to provide immobilization and stabilization of spinal segments in skeletally mature
patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformit ies of the thoracic,
lumbar, and sacral spine: severe spondylolisthesis of vertebra; degenerative spondylolisthesis with objective evidence of
neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion pseud arthrosis.
N.3075 Posterior cervical screw
system2 Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials (e.g.,
stainless steel, pure titanium, titanium alloy, etc.) that allow an implant system to be built from the occiput to the upper thoracic
spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross- sectional imaging. Such
a spinal assembly consists of a combination of bone anchors via scr ews (i.e., occipital screws, cervical lateral mass screws, cervical
pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods,
including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-
rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rig idly
fixed devices that do not contain dynamic features, including but not limited to: non- uniform longitudinal elements or features that
allow more motion or flexibility compared to rigid systems. Posterior cervical screw systems are intended to provide
immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the
cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: traumatic spinal fractures and/or trau matic
dislocations, deformities, instabilities, failed previous fus ions (e.g., pseudarthrosis), tumors, inflammatory disorders, spinal
degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI),
degeneration of the facets with instability; and reconstruction fo llowing decompression to treat radiculopathy and/or myelopathy.
N.3080 Intervertebral body fusion
device2,3 An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materi als,
including titani um and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine,
and is intended for intervertebral body fusion.
Classification: (1) Class 2 for intervertebral body fusion devices that contain bone grafting m aterial. (2) Class 3 for intervertebral
body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein)
N.3100 Ankle joint metal/composite 2 An ankle joint metal/composite semi-constrained ce mented prosthesis is a device intended to be implanted to replace an anklesemi-constrained cemented
prosthesisjoint. The device limits translation and rotation: in one or more planes via the geometry of its articulating surfaces. It ha s no linkage
across-the-joint. This generic type of devi ce includes prostheses that consist of a talar resurfacing component made of alloys, such
as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from ultra- high molecular weight polyethylene
with carbon fibers composite, and is limited to those prostheses intended for use with bone cement.
N.3110 Ankle joint metal/polymer
semi-constrained cemented
prosthesis2 An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joi nt.
The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no lin kage
across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as
cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra- high molecular weight polyethylene and is
limited to those prostheses intended for use with bone cement.
N.3120 Ankle joint metal/polymer
non-constrained cemented
prosthesis3 An ankle joint metal/polymer non- constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-
the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-
molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses i ntended
for use with bone cement.
N.3150 Elbow joint metal/metal or
metal/polymer constrained
cemented prosthesis2 An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It
is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra- high molecular weight polyethylene
bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked toget her.
This generic type of device is limited to those prostheses intended for use with bone cement.
N.3160 Elbow joint metal / polymer
semi-constrained cemented
prosthesis2 An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be impl anted to replace an elbow joint.
The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no lin kage
across-the-joint. This generic type of device includes prostheses that consist of a humeral r esurfacing component made of alloys,
such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra- high molecular weight polyethylene.
This generic type of device is limited to those prostheses intended for use with bone cement.
N.3170 Elbow joint radial (hemi-
elbow) polymer prosthesis2 An elbow joint radial (hemi- elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone
elastomer used to replace the proximal end of the radius.
N.3180 Elbow joint humeral (hemi-
elbow) metallic uncemented
prosthesis3 An elbow joint humeral (hemi- elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such
as cobalt-chromium-molybdenum, that is used to replace the distal end of th e humerus formed by the trochlea humeri and the
capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement.
N.3200 Finger joint metal / metal
constrained uncemented
prosthesis3 A finger joint metal/metal c onstrained uncemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic pla ne
and consists of two components which are link ed together. This generic type of device includes prostheses made of alloys, such ascobalt-chromium-molybdenum, or protheses made from alloys and ultra- high molecular weight polyethylene. This generic type
of device is limited to prostheses intended for use without bone cement.
N.3210 Finger joint metal / metal
constrained cemented
prosthesis3 A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalang eal
(finger) joint. This device preve nts dislocation in more than one anatomic plane and has components which are linked together.
This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium- molybdenum, and is limited to
those prostheses intended for use with bone cement.
N.3220 Finger joint metal / polymer
constrained cemented
prosthesis3 A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane,
and consists of two components which are linked together. This generic type of device includes prostheses that are made of al loys,
such as cobalt-chromium-molybdenum, and ultra-high m olecular weight polyethylene, and is limited to those prostheses intended
for use with bone cement.
N.3230 Finger joint polymer
constrained prosthesis2 A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metac arpophalangeal or proximal
interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the- joint
component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-
the-joint component may be covered with a silicone rubber sleeve.
N.3300 Hip joint metal constrained
cemented or uncemented
prosthesis3 A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The
device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of
device includes prostheses that have components made of alloys, such as cobalt-chromium-mol ybdenum, and is intended for use
with or without bone cement. This device is not intended for biological fixation.
N.3310 Hip joint metal/polymer
constrained cemented or
uncemented prosthesis2 A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip
joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This gene ric
type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium- molybdenum, and an
acetabular component made of ultra-high-molecular- weight polyethylene with or without a metal shell, made of alloys, such as
cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement.
N.3320 Hip joint metal/metal semi-
constrained, with a
cemented acetabular
component, prosthesis3 A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two- part device intended to be
implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its ar ticulating
surfaces. It has no linkage across-the-joint. This generic type of device includes prosthese s that consist of a femoral and an
acetabular component, both made of alloys, such as cobalt-chromium- molybdenum. This generic type of device is limited to those
prostheses intended for use with bone cement.
N.3330 Hip joint metal/metal semi-
constrained, with an3 A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two- part device intended to
be implanted to replace a hip joint. The device limits translation and rota tion in one or more planes via the geometry of itsuncemented acetabular
component, prosthesisarticulating surfaces. It has no linkage across-the- joint. This generic type of device includes prostheses that consist of a femoral
and an acetabular component, both made of alloys, such as cobalt-chromium- molybdenum. The femoral component is intended to
be fixed with bone cement. The acetabular component is intended for use without bone cement.
N.3340 Hip joint metal/composite
semi-constrained cemented
prosthesis2 A hip joint metal/composite semi-constrained cemented prosthesis is a two- part device intended to be implanted to replace a hip
joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage
across-the-joint. This generi c type of device includes prostheses that consist of a femoral component made of alloys, such as
cobalt-chromium-molybdenum, and an acetabular component made of ultra- high molecular weight polyethylene with carbon
fibers composite. Both components are intended for use with bone cement.
N.3350 Hip joint metal/polymer
semi-constrained cemented
prosthesis2 A hip joint metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The
device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-
the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-
molybdenum, and an acetabular resurfacing component made of ultra- high molecular weight polyethylene and is limited to those
prostheses intended for use with bone cement.
N.3353 Hip joint metal / ceramic /
polymer semi-constrained
cemented or nonporous
uncemented prosthesis2 A hip joint metal/ceramic/polymer semi- constrained cemented or nonporous uncemented prosthesis is a device intended to be
implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articul ating
surfaces. It has no linkage across-the-joint. The two- part femoral component consists of a femoral stem made of alloys to be fixed
in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femor al stem
is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femor al
component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra- high molecular weight
polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
N.3358 Hip joint metal / polymer /
metal semi-constrained
porous-coated uncemented
proshesis2 A hip joint metal/polymer/metal semi-constrained porous-coated uncemen ted prosthesis is a device intended to be implanted to
replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating su rfaces. It
has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium- molybdenum
(Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra- high
molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al- 4V . The femoral
stem and acetabular shell have a porous coating made of, in the case of Co-Cr- Mo substrates, beads of the same alloy, and in the
case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity
between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating
thickness between 500 and 1,500 microns. The generic type of device has a design t o achieve biological fixation to bone without
the use of bone cement.
N.3360 Hip joint femoral(hemi- hip) 2 A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be imp lanted to replace a portionmetallic cemented or
uncemented prosthesisof the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-
chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to t he bone with bone cement
as well as designs which have large window- like holes in the stem of the device and which are intended for use without bone
cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
N.3370 Hip joint (hemi-hip)
acetabular metal cemented
prosthesis3 A hip joint (hemi- hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip
joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium-
molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement.
N.3380 Hip joint femoral(hemi-hip)
trunnion-bearing
metal/polyacetal cemented
prosthesis3 A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis is a two- part device intended to be implanted
to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a met allic stem made of
alloys, such as cobalt-chromium- molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that
fits into a recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) a nd it is covered by
a metallic alloy, such as cobalt-chromium- molybdenum. The trunnion bearing allows the head of the device to rotate on its stem.
The prosthesis is intended for use with bone cement.
N.3390 Hip joint femoral(hemi-hip)
metal/polymerl cemented or
uncemented prosthesis2 A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two- part device intended to be implanted to
replace the head and neck of the femur. This generic type of device includes prostheses that h ave a femoral component made of
alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-
molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone
cement or implanted by impaction.
N.3400 Hip joint femoral(hemi-hip)
metallic resurfacing
prosthesis2 A hip joint femoral (hemi- hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip
joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-
chromium-molybdenum.
N.3410 Hip joint metal/polymer
semi-constrained
resurfacing cemented
prosthesis3 A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two- part device intended to
be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. The device limits tr anslation
and rotation in on e or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type
of device includes prostheses that consist of a femoral cap component made of a metal alloy, such as cobalt-chromium-
molybdenum, or a cera mic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer
component. Both components are intended for use with bone cement.
N.3480 Knee joint femorotibial
metallic constrained
cemented prosthesis3 A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee
joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. The only knee
joint movement allowed by the device is in the sagittal plane. This generic type of device includes prostheses that have an
intramedullary stem at both the proximal and distal locations. The upper and lower components may be joined either by a solidbolt or pin, an internally threaded bolt with locking screw, or a bolt retained by circlip. The components of the device are made of
alloys, such as cobalt-chromium- molybdenum. The stems of the device may be perforated, but are intended for use with bone
cement.
N.3490 Knee joint femorotibial
metal/composite non-
constrained cemented
prosthesis2 A knee joint femorotibial metal/composite non- constrained cemented prosthesis is a device intended to be implanted to replace
part of a knee joint. The device limits mini mally (less than normal anatomic constraints) translation in one or more planes. It has
no linkage across-the- joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component
or components made of alloys, such as cobalt-chromium- molybdenum, and a tibial condylar component or components made of
ultra-high molecular weight polyethylene with carbon fibers composite and are intended for use with bone cement.
N.3500 Knee joint femorotibial
metal/composite semi-
constrained cemented
prosthesis2 A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two- part device intended to be implanted to
replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating
surfaces. It has no linkage across-the- joint. This generic type of device includes prostheses that have a femoral component made
of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra- high
molecular weight polyethylene with carbon- fibers composite and is limited to those prostheses intended for use with bone cement.
N.3510 Knee joint femorotibial
metal/polymer constrained
cemented prosthesis2 A knee joint femorotibia l metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a
knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or af fined.
This generic type of device includes prostheses composed of a ball-and- socket joint located between a stemmed femoral and a
stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and- socket joint
is composed of a bal l at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau,
and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium- molybdenum. The ball of the
tibial component is he ld within the socket of the femoral component by the femoral component's flat outer surface. The flat outer
surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges o n the
femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as
cobalt-chromium-molybdenum, but the socket of the component is made of ultra- high molecular weight polyethylene. The femoral
component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press- fit into the metallic
tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passi ng
through a journal bea ring of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction.
This generic type of device is limited to those prostheses intended for use with bone cement.
N.3520 Knee joint femorotibial
metal/polymer non-
constrained cemented
prosthesis2 A knee joint femorotibial metal/polymer non- constrained cemented prosthesis is a device intended to be implanted to replace part
of a knee joint. The device limits minimally (less than normal anatomic constraints) transla tion in one or more planes. It has no
linkage across-the- joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or
components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra- highmolecular weight polyethylene and are intended for use with bone cement.
N.3530 Knee joint femorotibial
metal/polymer semi-
constrained cemented
prosthesis2 A knee joint femorotibial metal/polymer semi-constrained cemented pr osthesis is a device intended to be implanted to replace part
of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfac es. It has
no linkage across-the-joint. This generic type of device i ncludes prostheses that consist of a femoral component made of alloys,
such as cobalt-chromium-molybdenum, and a tibial component made of ultra- high molecular weight polyethylene and is limited
to those prostheses intended for use with bone cement.
N.3535 Knee joint femorotibial
unicompartmental
mental/polymer porous-
coated uncemented
prosthesis2 A knee joint femorotibial (uni-compartmental) metal/polymer porous- coated uncemented prosthesis is a device intended to be
implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its
articulating surface. It has no linkage across-the- joint. This generic type of device is designed to achieve biological fixation to
bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra- high molecular
weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.
N.3540 Knee joint patellofemoral
polymer/metal semi-
constrained cemented
prosthesis2 A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two- part device intended to be implanted to
replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device l imits translation
and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the- joint. This generic type
of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the
intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra- high
molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement. The
patellar component is designed to be implanted only with its femoral component.
N.3550 Knee joint
patellofemorotibial
polymer/metal/metal
constrained cemented
prosthesis3 A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to
replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked toge ther.
This generic type of device includes prostheses that have a femor al component, a tibial component, a cylindrical bolt and
accompanying locking hardware that are all made of alloys, such as cobalt-chromium- molybdenum, and a retropatellar resurfacing
component made of ultra-high molecular weight polyethylene. The retropat ellar surfacing component may be attached to the
resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are in tended
for use with bone cement.
N.3560 Knee joint
patellofemorotibial
polymer/metal/polymer
semi-constrained cemented
prosthesis2 A knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted
to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces.
It has no linkage across-the- joint. This generic type of device includes prostheses that have a femoral component made of alloys,
such as cobalt-chromium-molybdenum, and a tibial component or co mponents and a retropatellar resurfacing component made of
ultra- high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone
cement.N.3565 Knee joint
patellofemorotibial
metal/polymer porous-
coated uncemented
prosthesis2 A knee joint patellofemorotibial metal/polymer porous- coated uncemented prosthesis is a device intended to be implanted to
replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces.
It has no linkage across-the- joint. This generic type of device is designed to achieve biological fixation to bone without the use of
bone cement. This identification includes fixed-bearing knee prostheses where the ultra hig h molecular weight polyethylene tibial
bearing is rigidly secured to the metal tibial base plate.
N.3570 Knee joint femoral (hemi-
knee) metallic uncemented
prosthesis3 A knee joint femoral (hemi-knee) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-
molybdenum, intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or mo re
planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This gen eric type of device includes
prostheses that consist of a femoral component with or without protuberance(s) for the enhancement of fixation and is limited to
those prostheses intended for use without bone cement.
N.3580 Knee joint patellar (hemi-
knee) metallic resurfacing
uncemented prosthesis2,3 A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium-
molybdenum, intended to be implanted to replace the retropatellar articular surfac e of the patellofemoral joint. The device limits
minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the- joint. This generic
type of device includes prostheses that have a retropatellar resurfacing component and an orthopedic screw to transfix the patellar
remnant. This generic type of device is limited to those prostheses intended for use without bone cement. Classification: (1 )
Class 2 when intended for treatment of degenerative and posttraumatic patellar arthritis. (2) Class 3 when intended for uses other
than treatment of degenerative and posttraumatic patellar arthritis.
N.3590 Knee joint tibial (hemi-
knee) metallic resurfacing
uncemented prosthesis2 A knee joint tibial (hemi-knee) metallic re surfacing uncemented prosthesis is a device intended to be implanted to replace part of
a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has n o
linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium- molybdenum, and is intended to resurface
one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement.
N.3640 Shoulder joint metal/metal
or metal/polymer
constrained cemented
prosthesis3 A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a
shoulder joint. The device prevents dislocation in more than one anatomic plane and has componen ts that are linked together. This
generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium- molybdenum,
and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecula r weight polyethylene. This
generic type of device is limited to those prostheses intended for use with bone cement.
N.3650 Shoulder joint metal /
polymer non-constrained
cemented prosthesis2 A shoulder joint metal/polymer non-constrained cemented prost hesis is a device intended to be implanted to replace a shoulder
joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linka ge
across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-
chromium-molybdenum, and a glenoid resurfacing component made of ultra- high molecular weight polyethylene, and is limited
to those prostheses intended for use with bone cement.N.3660 Shoulder joint
metal/polymer semi-
constrained cemented
prosthesis2 A shoulder joint metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted to replace a shoulder
joint. The device limits translation and rotation in one or more pl anes via the geometry of its articulating surfaces. It has no linkage
across-the- joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such
as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra- high molecular weight polyethylene, and
is limited to those prostheses intended for use with bone cement.
N.3670 Shoulder joint
metal/polymer/metal
nonconstrained or
semiconstrained porous-
coated uncemented
prosthesis2 A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous- coated uncemented prosthesis is a device
intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-
the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-
molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al- 4V) alloys, and a glenoid resurfacing component made of
ultra-high molecular weight polyethylene, or a combination of an articulating ultra- high molecular weight bearing surface fixed in
a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al- 4V . The humeral component and glenoid backing have a porous coating
made of, in the case of Co-Cr- Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of
Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al- 4V alloy, or commercially pure titanium powder.
The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns,
interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is design ed
to achieve biological fixation to bone without the use of bone cement.
N.3680 Shoulder joint glenoid
(hemi-shoulder)metallic
cemented prosthesis3 A shoulder joint glenoid (hemi- shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of
alloys, such as cobalt-chromium-molybdenum, or alloys with ultra- high molecular weight polyethylene and intended to be
implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use wi th bone
cement.
N.3690 Shoulder joint humeral
(hemi-shoulder)metallic
uncemented prosthesis2 A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-
molybdenum. It has an intramedullary stem and is intended to be impla nted to replace the articular surface of the proximal end of
the humerus and to be fixed without bone cement. This device is not intended for biological fixation.
N.3720 Toe joint polymer
constrained prosthesis2 A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer
intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single
flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
N.3730 Toe joint phalangeal (hemi-
toe)polymer prosthesis2 A toe joint phalangeal (hemi- toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace
the base of the proximal phalanx of the toe.
N.3750 Wrist joint carpal lunate
polymer prosthesis2 A wrist joint carpal lunate prosthesis is a one- piece device made of silicone elastomer intended to be implanted to replace the
carpal lunate bone of the wrist.
N.3760 Wrist joint carpal scaphoid 2 A wrist joint carpal scaphoid polymer prosthesis is a one- piece device made of silicone elastomer intended to be implanted topolymer prosthesis replace the carpal scaphoid bone of the wrist.
N.3770 Wrist joint carpal trapezium
polymer prosthesis2 A wrist joint carpal trapezium polymer prosthesis is a one- piece device made of silicone elastomer or silicone elastomer/polyester
material intended to be implanted to replace the carpal trapezium bone of the wrist.
N.3780 Wrist joint polymer
constrained prosthesis2 A wrist joint polymer constrained prosthesis is a device made of polyester- reinforced silicone elastomer intended to be implanted
to replace a wrist joint. This generic type of device consists of a single flexible across-the- joint component that prevents dislocation
in more than one anatomic plane.
N.3790 Wrist joint metal
constrained cemented
prosthesis3 A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. T he device
prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the- joint component or two
components linked together. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium-
molybdenum, and is limited to those prostheses intended for use with bone cement.
N.3800 Wrist joint metal/polymer
semi-constrained cemented
prosthesis2 A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to b e implanted to replace a wrist joint.
The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no lin kage
across-the-joint. This generic type of device includes prostheses that have either a one- part radial component made of alloys, such
as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two- part radial
component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a
trunnion bearing. The metallic portion of the two- part radial component is inserted into the radius. These devices have a metacarpal
component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses
intended for use with bone cement.
N.3810 Wrist joint ulnar(hemi-
wrist) polymer prosthesis2 A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom- shaped device made of a medical grade silicone elastomer or
ultra- high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by
a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surfa ce
for the radius and carpus.
N.4150 Calipers for clinical use 1 A caliper for clinical use is a compass- like device intended for use in measuring the thickness or diameter of a part of the body or
the distance between two body surfaces, such as for measu ring an excised skeletal specimen to determine the proper replacement
size of a prosthesis.
N.4200 Cement dispenser 1 A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement into surgical sites.
N.4210 Cement mixer for clinical
use1 A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement
N.4220 Cement monomer vapor
evacuator1 A cement monomer vapor evacuator is a device intended for use during surgery to conta in or remove undesirable fumes, such as
monomer vapor from bone cement
N.4230 Cement ventilation tube 1 A cement ventilation tube is a tube- like device usually made of plastic intended to be inserted into a surgical cavity to allow therelease of air or fluid from the cavity as it is being filled with bone cement
N.4300 Depth gauge for clinical use 1 A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper l ength
of screws for fastening the ends of a fractured bone.
N.4540 Orthopedic manual surgical
instrument1 An orthopedic manual surgical instrument is a nonpowered hand- held device intended for medical purposes to manipulate tissue,
or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill
brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holde r, impactor,
bending or contouring instrument, compr ession instrument, passer, socket positioner, probe, femoral neck punch, socket pusher,
reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trep hine, wire
twister, and wrench.
N.4580 Sonic surgical instrument
and accessories/attachments2 A sonic surgical instrument is a hand- held device with various accessories or attachments, such as a cutting tip that vibrates at high
frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
N.4600 Protractor for clinical use 1 A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
N.4800 Template for clinical use 1 A template for clinical u se is a device that consists of a pattern or guide intended for medical purposes, such as selecting or
positioning orthopedic implants or guiding the marking of tissue before cutting.
N.5850 Nonpowered orthopedic
traction apparatus and
accessories1 A non powered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such
as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
N.5890 Noninvasive traction
component1 A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetra te the skin
and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic p ulling force may be applied to the
patient's body.
N.5940 Cast component 1 A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the
cast heel, toe cap, cast support, and walking iron.
N.5960 Cast removal instrument 1 A cast removal instrument is an AC-powered, hand- held device intended to remove a cast from a patient. This generic type of
device includes the electric cast cutter and cast vacuum.
N.5980 Manual cast application
and removal instrument1 A manual cast application and removal instrument is a nonpowered hand- held device intended to be used in applying or removing
a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.
N.9999 Others(Orthopedic Devices) 1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
O.0001 Static electric therapy
apparatus2 A static e lectric therapy apparatus is a device applying electrical field to human body and intended to relieve shoulder stiffness,
headache, and chronic constipation. This type of device generally contains voltage transformer circuit, safety circuit, recti ficationcircuit, electrodes, and insulators. The device uses safety circuit to limit its output current and creates a voltage of appr oximately
600 to 10,000 volts.
O.0002 Non-invasive bone growth
stimulator3 The non-invasive bone growth stimulator is a non-invas ive device used to promote bone growth. This device can use magnetic
fields or other working principle to stimulate fracture bones to accelerate healing.
O.0003 Topical refrigerant 1 Topical refrigerant is the non-medicated spray used to rapid cooling of skin.
O.0005 Optical position/movement
recording system2 An optical position/movement recording system is a device that monitors the movement of a patient's body. The device assists a
patient for rehabilitation and provides the information to health professionals for evaluating the rehabilitation status of a patient.
O.0006 Continuous Passive Motion
Device1 Continuous passive motion device is to move a specific joint of the patient through the designed range of motions without app lying
force. This devic e aids patients, who suffer joint replacement surgery or with neurological disease, to increase the range of joint
motion.
O.0007 Wheelchair positioning
devices1 A wheelchair positioning device is a device intended for medical purposes that is used with a wheelchair. This device is intended
as an aid in supporting and stabilizing patients with abnormal muscle tone to maintain the sitting posture of the wheelchair. This
device may include: 1) A wheelchair backrest with a conformal rigid base and a soft cus hion. 2) A wheelchair positioning stand
with an adjustable mechanical structure that is locked on the wheelchair or the backrest. 3) A wheelchair headrest system wit h
adjustable support height, fore-aft position, and angle. 4) An accessory attached to the wheelchair utilizes a contoured seat surface
to provide support for the pelvis, hip joints, inner and outer thighs, thus preventing deformation due to abnormal muscle tension.
O.1175 Electrode cable 1 An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and
intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
O.1225 Chronaximeter 2 A chronaximeter is a device intended for medical purposes to measure neuromuscular excitability by means of a strength- duration
curve that provides a basis for diagnosis and prognosis of neurological dysfunction.
O.1375 Diagnostic electromyograph 2 A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals
produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, f or the
diagnosis and prognosis of neuromuscular disease.
O.1385 Diagnostic electromyograph
needle electrode2 A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve t issue
to sense bioelectrical signals. The device is intended for medical purposes for use in con nection with electromyography (recording
the intrinsic electrical properties of skeletal muscle).
O.1450 Powered reflex hammer 2 A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon
reflexes.
O.1575 Force-measuring platform 1 A force- measuring platform is a device intended for medical purposes that converts pressure applied upon a planar surface into
analog mechanical or electrical signals. This device is used to determine ground reacti on force, centers of percussion, centers oftorque, and their variations in both magnitude and direction with time.
O.1600 Intermittent pressure
measurement system1 An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual
pressure between the body surface and the supporting media.
O.1615 Miniature pressure
transducer1 A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device a nd soft tissue
by converting mechanical inputs to analog electrical signals.
O.1850 Diagnostic muscle
stimulator2 A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is int ended
for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.
O.1925 Isokinetic Testing and
Evaluation System1 An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medi cal purposes, such as to measure,
evaluate, and increase the strength of muscles and the range of motion of joints.
O.3025 Prosthetic and orthotic
accessory1 A prosthetic and orthotic accessory is a device intended for medical purposes to support, protec t, or aid in the use of a cast, orthosis
(brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt , a cast
shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary
training splint.
O.3075 Cane 1 A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of ca nes
include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.
O.3100 Mechanical chair 1 A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in
performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs
include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position a nd a chair
with casters used by a person to move from one place to another while sitting.
O.3110 Electric positioning chair 2 An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be
adjusted to various positions . The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter
postural positions.
O.3150 Crutch 1 A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weigh t support
while walking.
O.3175 Flotation cushion 1 A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, tha t is filled
with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.
O.3410 External limb orthotic
component1 An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to
increase the fun ction of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the
following: A brace-setting twister and an external brace stirrup.
O.3420 External limb prosthetic 1 An external limb prosthetic com ponent is a device intended for medical purposes that, when put together with other appropriatecomponent components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foo t,
hip, knee, and socket components ; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and
cable and prosthesis suction valves.
O.3450 Upper extremity prosthesis 2 An upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous
powered degrees of freedom and controlled by non- implanted electrical components, is a device intended for medical purposes,
and is intended to replace a partially or fully amputated or congenitally absent upper extremit y. It uses electronic inputs (other than
simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneousl y
powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are
intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity
prosthesis system.
O.3475 Limb orthosis 1 A limb orthosis (brace) is a device intended for medica l purposes that is worn on the upper or lower extremities to support, to
correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the
following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
O.3480 Powered lower extremity
exoskeleton2 A powered lower extremity exoskeleton is a device that is composed of an external, powered, motorized orthosis that is placed
over a person's paralyzed or weakened limbs for medical purposes.
O.3490 Truncal orthosis 1 A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of th e neck
or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo- sacral,
rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
O.3500 External assembled lower
limb prosthesis1 An external assembled lower limb prosthesis is a device tha t is intended for medical purposes and is a preassembled external
artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following:
Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.
O.3520 Plinth 1 A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treat ment or
examination.
O.3610 Rigid pneumatic structure
orthosis3 A rigid pneumatic structure orthosis is a device int ended for medical purposes to provide whole body support by means of a
pressurized suit to help thoracic paraplegics walk.
O.3640 Arm sling /triangle bandage 1 An arm sling /triangle bandage is a device intended for medical purposes to immobilize or bandage up a part of a patient's body.
This device is not elastic. It may include the following areas: head, chest, arms, ankles, hands and knees.
O.3665 Congenital hip dislocation
abduction splint1 A congenital hip dislocation abduction splint is a device inte nded for medical purposes to stabilize the hips of a young child with
dislocated hips in an abducted position (away from the midline).
O.3675 Denis Brown splint 1 A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial
torsion (excessive rotation of the lower leg) or club foot.O.3690 Powered wheeled stretcher 2 A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who
are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because
of skin ulcers or contractures (muscle contractions).
O.3750 Mechanical table 1 A mechanical table is a device intended for m edical purposes that has a flat surface that can be inclined or adjusted to various
positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increase tolerance to an u pright or
standing position.
O.3760 Powered table 1 A powered table is a device intended for medical purposes that is an electrically operated flat surface table that can be adj usted to
various positions. It is used by patients with circulatory, neurological, or musculoskeletal conditions to increase tolerance to an
upright or standing position.
O.3800 Motorized vehicle for
medical purposes2 A motorized vehicle for medical purposes is a gasoline-fueled or battery- powered device intended for medical purposes that is
used for transportation by mobility disabled persons. The maximum speed limit of motorized vehicles for medical purposes is 10
km/h.
O.3825 Mechanical walker 1 A mechanical walker is a four- legged device with a metal frame intended for medical purposes to provide moderate weight support
while walking. It is used by disabled persons who lack strength, good balance, or endurance.
O.3850 Mechanical wheelchair 1 A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility t o
person s restricted to a sitting position.Mechanical wheelchairs shall comply with the performance requirements of national
standard CNS 14964-8, ISO 7176-8 or equivalent international standards.
O.3860 Powered wheelchair 2 A powered wheelchair is a battery-oper ated device with wheels that is intended for medical purposes to provide mobility to persons
restricted to a sitting position. The maximum speed limit of powered wheelchairs is 10 km/h. This classification contains ext ernal
power components for use in mechanical wheelchairs
O.3880 Special grade wheelchair 2 A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restr icted
to a sitting position. It is intended to be used in all environments for long- term use, e.g., for paraplegics, quadraplegics, and
amputees.
O.3890 Stair-climbing wheelchair 2 A stair- climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted
to a sitting position. The device is intended to climb stairs.
O.3900 Standup wheelchair 2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a
sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic
to an upright position by means of an elevating seat.
O.3930 Mobile wheelchair elevator 1,2 A wheelchair elevator is a motorized lift device intended for medical purposes.(a) Pr oviding a means for a disabled person sitting
on a wheelchair to move from one level to another. Classification: Class 2.
(b) Devices that are operated by an accompany person. Classification: Class 1. The devices are required to meet the electrica lsafety standard (e.g., IEC 60601-1) and performance standard (e.g., ISO 7176-28 or the other equivalent international standards).
O.5100 Immersion hydrobath 2 An immersion hydrobath is a device intended for medical purposes that consists of water agitators and t hat may include a tub to
be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itchin g and
as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
O.5110 Paraffin bath 2 A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained
at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.
O.5125 Nonpowered sitz bath 1 A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in ex ternal
hydrotherapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal
areas.
O.5150 Powered patient transport 1,2 (a)A powered patient transport is a motorized device intended for medical purposes to assist transfers of patients to and from the
bath, beds, chairs, treatment modalities, transport vehicles, and up and down flights of stairs. This generic type of device does not
include motorized three-wheeled vehicles or wheelchairs. Classification: Class 2.
(b) Devices th at are operated by an accompany person. Classification: Class 1. The devices are required to meet the electrical
safety standard (e.g., IEC 60601-1) and performance standard (e.g., ISO 7176-28 or the other equivalent international standards).
O.5160 Air-fluidized bed 1 An air- fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects)
that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.
O.5170 Powered flotation therapy
bed1 A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly movin g
water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive
burns, or to aid circulation. The mattress may be electrically heated.
O.5180 Manual patient rotation bed 1 A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical
purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.
O.5225 Powered patient rotation bed 1 A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical
purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.
O.5250 Moist steam cabinet 2 A moist steam cabinet is a device inte nded for medical purposes that delivers a flow of heated, moisturized air to a patient in an
enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.
O.5275 Microwave diathermy 2,3 (a)Microwave diathermy for use in applying therapeutic deep heat for selected medical conditions -- (1)Identification. A
microwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to
specific areas of the b ody electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz
and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relie f
of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. (2)Classification: Class 2.
(b)Microwave diathermy for all other uses -- (1)Identification. A microwave diathermy for all other uses except for the treatmentof malignancies is a device that applies to the body electromagnetic energy in the microwave frequency bands of 915
megahertz to 2,450 megahertz and that is intended for the treatment of medical conditions by means other than the generation
of deep heat within body tissues as described in paragraph (a) of this section.(2)Classification: Class 3.
O.5290 Shortwave diathermy 2,3 (a)Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions -- (1)Identification: A shortwave
diathermy for use in applying therapeutic deep he at for selected medical conditions is a device that applies to specific areas
of the body electromagnetic energy in the radio frequency bands of 13 megahertz to 27.12 megahertz and that is intended to
generate deep heat within body tissues for the treatmen t of selected medical conditions such as relief of pain, muscle spasms,
and joint contractures, but not for the treatment of malignancies. (2)Classification: Class 2.
(b)Shortwave diathermy for all other uses --(1)Identification: A shortwave diathermy for all other uses except for the treatment
of malignancies is a device that applies to the body electromagnetic energy in the radio frequency bands of 13 megahertz to
27.12 megahertz and that is intended for the treatment of medical conditions by means other tha n the generation of deep heat
within body tissues as described in paragraph (a) of this section. (2) Classification: Class 3.
O.5300 Ultrasonic diathermy 2,3 (a)Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions -- (1)Identification: An
ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to
specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generat e deep heat
within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint
contractures, but not for the treatment of malignancies. (2) Classification: Class 2.
(b)Ultrasonic diathermy for all other uses -- (1)Identification: An ultrasonic diathermy for all other uses except for the treatment
of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intende d
for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in
paragraph (a) of this section. (2) Classification: Class 3.
O.5360 Measuring exercise
equipment2 Measuring exercise equipment consist of manual devices intended for medic al purposes, such as to redevelop muscles or restore
motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as
electrocardiograph, spirometer and sphygmomanometer, that provide information used for physical evaluation.
O.5500 Infrared lamp 2 An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700
nanometers to 50,000 nanometers) to provide topical heating.
O.5525 Iontophoresis device 2 (a)Iontophoresis device intended for certain specified uses - Identification: An iontophoresis device is intended for use in the
diagnosis of cystic fibrosis or is used along with certain drugs to achieve specific functions. This device uses a current to
introduce ions of soluble salts or certain drugs into the patient's body for inducing sweating. This device collects patient's
sweat and determines its composition and weight to diagnose cystic fibrosis. Classification: Class 2.
(b)Iontophoresis device intended for any other purposes - Identification: An iontophoresis device intended for certain specifieduses other than those referred to in paragraph (a) above. This device uses a current to introduce ions of drugs or non- drug
solutions into the patient's body for achieving specific medical purposes. Classification: Class 2.
O.5575 Powered external limb
overload warning device2 A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an
underload in the amount of pressure placed on a leg.
O.5650 Powered inflatable tube
massager2 A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches a nd
pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
O.5700 Cold/ Hot pack 1 A cold/hot pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated
pliable silicate gel or a flexible bandage consists of non- medical liquid capable of forming to the contour of the body and that
provides cold/hot therapy for body surfaces.
O.5710 Hot or cold disposable pack 1 A hot or cold disposable pack is a device int ended for medical purposes that consists of a sealed plastic bag incorporating chemicals
that, upon activation, provides hot or cold therapy for body surfaces.
O.5720 Water circulating hot or cold
pack1 A water circulating hot or cold pack is a device in tended for medical purposes that operates by pumping heated or chilled water
through a plastic bag and that provides hot or cold therapy for body surfaces.
O.5730 Moist heat pack 1 A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated
temperature and that provides moist heat therapy for body surfaces.
O.5740 Powered heating pad 1 A powered heating pad is an electrical device intended for medical purposes that provides dry h eat therapy for body surfaces. It is
capable of maintaining an elevated temperature during use.
O.5765 Pressure-applying device 1 A presssure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissu es
for muscular relaxation and neuro- inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's
hands, presses on the back of a prone patient.
O.5850 Powered muscle stimulator 2 A powered muscle stimulator is a n electrically powered device intended for medical purposes that repeatedly contracts muscles
by passing electrical currents through electrodes contacting the affected body area.
O.5860 Ultrasound and muscle
stimulator2,3 (a)Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions -- (1)Identification.
An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device tha t
applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep
heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint
contractures, but not for the treatme nt of malignancies. The device also passes electrical currents through the body area to
stimulate or relax muscles. (2) Classification: Class 2.
(b)Ultrasound and muscle stimulator for all other uses - (1) Identification. An ultrasound and muscle stimulator for all other uses
except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20
kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions b y meansother than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in
paragraph (a) of this section. (2) Classification: Class 3.
O.5880 Multi-function physical
therapy table2 A multi-function phy sical therapy table is a device intended for medical purposes that consists of a motorized table equipped to
provide patients with heat, traction, and muscle relaxation therapy.
O.5900 Powered traction equipment 2 Powered traction equipment consists of po wered devices intended for medical purposes for use in conjunction with traction
accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
O.5925 Traction accessory 1 A traction accessory is a nonpowered accessor y device intended for medical purposes to be used with powered traction equipment
to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter,
and pelvic belt.
O.9999 Others(Physical Medicine
Devices)1,2,3 The products excluded from the above- classification are adopted in this classification and specified by the central competent health
authority.
P.0002 Blood irradiator to prevent
graft versus host disease2 An ionizing radiati on blood irradiator is a device that generates ionizing radiation to irradiate blood and blood products (blood
packs), making the lymphoid cells in the blood deactivate for the prevention of graft versus host disease (GVHD).
P.1000 Magnetic resonance
diagnostic device2 A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial
distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear m agnetic
resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-
1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus- 31 spectroscopy, and chemical shift imaging
(preserving simultaneous frequency and spatial information).
P.1100 Scintillation (gamma)
camera1 A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a phot on
radiation detector. This gener ic type of device may include signal analysis and display equipment, patient and equipment supports,
radionuclide anatomical markers, component parts, and accessories.
P.1110 Positron camera 1 A positron camera is a device intended to image the distribution of positron- emitting radionuclides in the body. This generic type
of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers,
component parts, and accessories.
P.1130 Nuclear whole body counter 1 A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This generic typ e of
device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1170 Bone densitometer 2 A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x- ray or gamma
ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and accessories.
P.1180 Bone Sonometer 2 A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone thatindicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting
transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.
P.1200 Emission computed
tomography system2 An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-
emitting radionuclides in the body and produce cross-sectional images throu gh computer reconstruction of the data. This generic
type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical
markers, component parts, and accessories.
P.1220 Fluorescent scanner 2 A fluore scent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain
x-rays or low- energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and
equipment supports, component parts and accessories.
P.1300 Nuclear rectilinear scanner 1 A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detec tor (or
detectors) whose position moves in two d irections with respect to the patient. This generic type of device may include signal
analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and
accessories.
P.1310 Nuclear tomography system 2 A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-
sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include sig nal
analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and
accessories.
P.1320 Nuclear uptake probe 1 A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region.
This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient a nd
equipment supports, component parts, and accessories.
P.1330 Nuclear whole body scanner 1 A nu clear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means
of a wide- aperture detector whose position moves in one direction with respect to the patient. This generic type of device may
include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts,
and accessories.
P.1350 Nuclear scanning bed 1 A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.
P.1360 Radionuclide dose calibrator 2 A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
P.1390 Radionuclide rebreathing
system2 A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-
labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exc hange
between t he lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient
and equipment supports, component parts, and accessories.
P.1400 Nuclear sealed calibration 1 A nuclear sealed calibration source i s a device that consists of an encapsulated reference radionuclide intended for calibration ofsource medical nuclear radiation detectors.
P.1410 Nuclear electrocardiograph
synchronizer1 A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation
to the cardiac cycle during the production of dynamic cardiac images.
P.1540 Nonfetal ultrasonic monitor 2 A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wa ve into body tissue other than a fetus
to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood
flow and other nonfetal body tissues in motion. This generic type of device may inclu de signal analysis and display equipment,
patient and equipment supports, component parts, and accessories.
P.1550 Ultrasonic pulsed doppler
imaging system2 An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler- effect technology
with pulsed- echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location
of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue moti on. This generic type of device may
include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1560 Ultrasonic pulsed echo
imaging system2 An ultrasonic pulsed echo imaging system is a device intend ed to project a pulsed sound beam into body tissue to determine the
depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissu e interface
and back to the receiver. This generic type of devi ce may include signal analysis and display equipment, patient and equipment
supports, component parts, and accessories.
P.1570 Diagnostic ultrasonic
transducer2 A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals
and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of th is generic
type of device may include transmission media for acoustically coupling the tr ansducer to the body surface, such as acoustic gel,
paste, or a flexible fluid container.
P.1600 Angiographic x-ray system 2 An angiographic x- ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system
during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment,
patient and equipment supports, component parts, and accessories.
P.1610 Diagnostic x-ray beam-
limiting device2 A diagnostic x-ray beam- limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions
of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
P.1620 Cine or spot fluorographic
x-ray camera2 A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x- rays with an image
intensifier.
P.1630 Electrostatic x-ray imaging
system2 An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a
semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x- radiation into an electrostatic image
and, subsequently, into a visible image. This generic type of device may include signa l analysis and display equipment, patient
and equipment supports, component parts, and accessories.
P.1640 Radiographic film marking 1 A radiographic film marking system is a device intended for medical purposes to add identification and other info rmation ontosystem radiographic film by means of exposure to visible light.
P.1650 Image-intensified
fluoroscopic x-ray system2 An image-intensified fluoroscopic x- ray system is a device intended to visualize anatomical structures by converting a pattern of
x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, component parts, and accessories.
P.1660 Non-image-intensified
fluoroscopic x-ray system2 A non-image-intensified fluoroscopic x- ray system is a device intended to be used to visualize anatomical structures by using a
fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis
and display equipment, patient and equipment supports, component parts, and accessories.
P.1670 Spot-film device 2 A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical
purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.
P.1680 Stationary x-ray system 2 A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of
various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipm ent
supports, component parts, and accessories.
P.1700 Diagnostic x-ray high
voltage generator1 A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a
diagnostic x- ray tube for medical purposes. This generic type of device may include a converter that changes alternating current
to direct current, filament transformers for the x- ray tube, high voltage switches, electrical protective devices, or other appropriate
elements.
P.1710 Mammographic x-ray
system2 A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This ge neric type of device
may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1715 Full-field digital
mammography system2 A full-field digital mammography system(FFDM) is a device intended to produce planar digital x- ray images of the entire breast.
This generic type of device may include digital mammography acquisition software, full- field digital image receptor, acquisition
workstation, automatic exposure control, image processing and reconst ruction programs, patient and equipment supports,
component parts, and accessories.
P.1720 Mobile x-ray system 2 A mobile x-ray system is a transportable device system intended to be used to generate and control x- ray for diagnostic procedures.
This gener ic type of device may include signal analysis and display equipment, patient and equipment supports, component parts,
and accessories.
P.1730 Photofluorographic x-ray
system2 A photofluorographic x-ray system is a device that includes a fluoroscopic x-ra y unit and a camera intended to be used to produce,
then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipm ent,
patient and equipment supports, component parts, and accessories.
P.1740 Tomographic x-ray system 2 A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross- sectional plane
of the body by blurring or eliminating detail from other planes. This generic type of device may i nclude signal analysis and display
equipment, patient and equipment supports, component parts, and accessories.P.1750 Computed tomography x-
ray system2 A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional i mages of the body by
computer reconstruction of x- ray transmission data from the same axial plane taken at different angles. This generic type of device
may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1760 Diagnostic x-ray tube
housing assembly1 A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation- shielded housing that is intended for
diagnostic purposes. This generic type of device may include hi gh voltage and filament transformers or other appropriate
components.
P.1820 Pneumoencephalographic
chair2 A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x- ray
imaging of the brain).
P.1830 Radiologic patient cradle 1 A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient
during radiologic procedures.
P.1840 Radiographic film 1 Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a
photographic emulsion intended to record images during diagnostic radiologic procedures.
P.1850 Radiographic film cassette 2 A radiographic film cassette is a device intended for use during diagnostic x- ray procedures to hold a radiographic film in close
contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
P.1860 Radiographic film/cassette
changer2 A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic fil m or
cassette between x-ray exposures and to position it during the exposure.
P.1870 Radiographic film/cassette
changer programmer2 A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or casset te
changer during serial medical radiography.
P.1900 Automatic radiographic film
processor2 An automatic radiographic f ilm processor is a device intended to be used to develop, fix, wash, and dry automatically and
continuously film exposed for medical purposes.
P.1910 Radiographic grid 1 A radiographic grid is a device that consists of alternating radiolucent and radiopaq ue strips intended to be placed between the
patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
P.1920 Radiographic head holder 1 A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.
P.1960 Radiographic intensifying
screen1 A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that trans forms
incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
P.1970 Radiographic
ECG/respirator synchronizer1 A radiographic ECG/respirator synchronizer is a device intended to be used tocoordinatean x- ray film exposure with the signal
from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.
P.1980 Radiographic table 1 A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be
fixed or tilting and may be electrically powered.
P.1990 Transilluminator for breast 3 A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensityevaluation emissions of visible light and near-infrared radiation (approximately 700- 1050 nanometers (nm)), transmitted through the breast,
to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.
P.2010 Medical image storage
device1 A medical image sto rage device is a device that provides electronic storage and retrieval functions for medical images. Examples
include devices employing magnetic and optical discs, magnetic tape, and digital memory.
P.2020 Medical image
communication device1 A medical im age communications device provides electronic transfer of medical image data between medical devices. It may
include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality
for medical image proce ssing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric
measurements, compression, or user added image annotations. The device does not perform advanced image processing or
complex quantitative functions.
P.2030 Medical image digitizer 2 A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iys tems
employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
P.2040 Medical image hardcopy
device2 A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identifi cation
information. Examples include multiformat cameras and laser printers.
P.2050 Medical image management
and processing system2 A medical image management and processing system is a device that provides one or more capabilities relating to the review an d
digital processing of medical images for the purposes of interpretation by a trained practition er of disease detection, diagnosis, or
patient management. The software components may provide advanced or complex image processing functions for image
manipulation, enhancement, or quantification that are intended for use in the interpretation and analysi s of medical images.
Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization.
Complex quantitative functions may include semi-automated measurements or time-series measurements.
P.2060 Radiological Computer-
assisted diagnostic software
for lesions suspicious of
cancer2 A radiological computer- assisted diagnostic software for lesions suspicious of cancer is an image processing device intended to
aid in the characterization of lesions as su spicious for cancer identified on acquired medical images such as magnetic resonance,
mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted
from the images and provides information abo ut the lesion(s) to the user. Diagnostic and patient management decisions are made
by the clinical user.
P.2070 Radiological Medical image
analyzer2 Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breas t cancer,
ultrasound breast lesions, and radiograph lung nodules detection, is a device that is intended to identify, mark, highlight, or in any
other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities du ring interpretation
of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities an d
operates on previously acquired medical images. This device is not intended to replace the review by a qualif ied radiologist, and
is not intended to be used for triage, or to recommend diagnosis.
P.2080 Radiological computer 2 Radiological computer aided triage and notification software is an image processing device intende d to aid in prioritization andaided triage and notification
softwaretriage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensit ive
radiological medical images for review based on computer aided image analysis of those images pe rformed by the device. The
device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove
cases from a reading queue. The device operates in parallel with the standard of care, which rem ains the default option for all
cases.
P.5050 Medical charged-particle
radiation therapy system2 A medical charged- particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g.,
electrons and protons) int ended for use in radiation therapy. This generic type of device may include signal analysis and display
equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
P.5300 Medical neutron radiation
therapy system2 A medical neutron radiation therapy system is a device intended to generate high- energy neutrons for radiation therapy. This
generic type of device may include signal analysis and display equipment, patient and equipment support, treatment pl anning
computer programs, component parts, and accessories.
P.5650 Manual radionuclide
applicator system1 A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body o r
to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component
parts, treatment planning computer programs, and accessories.
P.5700 Remote controlled
radionuclide applicator
system2 A remote controlled radi onuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to
apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This gener ic type
of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
P.5710 Radiation therapy beam-
shaping block2 A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lea d) intended for medical
purposes to modify the shape of a beam from a radiation therapy source.
P.5720 Rectal balloon for prostate
immobilization2 A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device pl aced in the rectum to
immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation
therapy, including treatment planning, image verification, and radiotherapy delivery.
P.5725 Absorbable perirectal spacer 2 An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall awa y
from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior
rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely abso rbed
by the patient's body over time.
P.5730 Radionuclide brachytherapy
source2 A radionuclide brachyth erapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made
of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body
cavity or tissue as a source of nuclear radiation for therapy.
P.5740 Radionuclide teletherapy
source1 A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is inte nded
for radiation therapy, with the radiation source located at a distance from the patient's body.P.5750 Radionuclide radiation
therapy system2 A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, wit h
the radiation source locat ed at a distance from the patient's body. This generic type of device may include signal analysis and
display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-
limiting devices), and accessories.
P.5770 Powered radiation therapy
patient support assembly2 A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patien t
during radiation therapy.
P.5780 Light beam patient position
indicator1 A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine th e alignment
of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper
positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.
P.5840 Radiation therapy
stimulation system2 A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intende d for use in localizing the volume to
be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic
type of device may include signal analysis and display equipment, patient and equipme nt supports, treatment planning computer
programs, component parts, and accessories.
P.5900 X-ray radiation therapy
system2 An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type
of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer
programs, component parts, and accessories.
P.5930 Therapeutic x-ray tube
housing assembly2 A therapeutic x-ray tube housing assembly is an x-ray generating tube encased in a radiation- shielded housing intended for use in
radiation therapy. This generic type of device may include high- voltage and filament transformers or other appropriate components
when contained in radiation-shielded housing.
P.6500 Personnel protective shield 1 A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other person s from
unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type
of device may include articles of clothing, furniture, and movable or stationary structures.
P.9999 Others(Radiology Devices) 1,2,3 The products excluded from the above-classification are adopted in t his classification and specified by the central competent health
authority.