Regulations Governing
the Classification of Medical Devices
Article 1 The Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical
Devices Act (hereinafter referred to as “the Act”).
Article 2 Medical devices are classified into the following categories according to their
function, intended use, operating instructions, and working principle, depending
on the applicable medical specialty:
1. Clinical chemistry and clinical toxicology devices
2. Hematology, pathology, and genetics devices
3. Immunology and microbiology devices
4. Anesthesiology devices
5. Cardiovascular devices
6. Dental devices
7. Ear, nose, and throat devices
8. Gastroenterology and urology devices
9. General, plastic surgery, and dermatology devices
10. General hospital and personal use devices
11. Neurological devices
12. Obstetrical and gynecological devices
13. Ophthalmic devices
14. Orthopedic devices
15. Physical medicine devices
16. Radiology devices
Article 3 Medical devices are classified into the following classes according to their risk
level:
1. Class I: Low risk
2. Class II: Medium risk
3. Class III: High risk
Article 4 Product items of the medical device classification are specified in the Annex.
Medical device, except that it can be classified into anyone product item in the
Annex of the preceding paragraph, may be classified its class according to the
following rules with its special function, intended use, or working principle:
1. If two or more categories, classes, or product items are applicable to the
same medical device, the highest class of risk level is assigned.
2. The accessory to a medical device, intended specifically by the manufacturer
for use with a particular medical device, is classified the same class as the
particular medical device, unless otherwise specified in the Annex of the
preceding paragraph.
3. The classification of a combined product, which contains two or more
medical devices packaged together while having two or more categories,classes, or product items applicable, is assigned the highest class of risk level
among these devices.
4. A medical device containing medicine, which its primary mode of action is
attributable to its medical device, is determined to be a Class III medical
device, unless otherwise specified in the Annex of the preceding paragraph.
Article 5 Medical device firms or the public may make an inquiry to the central competent
authority regarding the classification of medical devices or other relevant matters.
Inquirers of the preceding paragraph shall fill out an inquiry form, provide the
following related documents and information, and pay the required fees for
submission to the central competent authority:
1. Instructions for use of the manufacturer: including operating instructions,
function, and working principle. If they are not in the traditional Chinese or
English version, a translation copy in traditional Chinese or English shall be
provided as well.
2. Classification reference information: reference information from the United
States of America, European Union, or other countries on the classification of
the inquired product. If such reference information is not available, it is not
required to be provided.
In addition to the above documents and information, when necessary, the central
competent authority may request the inquirer to provide other relevant documents
and information.
Article 6 If the function, intended use, or working principle of a medical device does not
meet identification criteria of any product item listed in the Annex, its
classification shall be determined to be a Class III medical device.
If a predicate device has been approved in registration or listed domestically, its
classification shall be determined according to the risk level of the predicate
device, or if a classification inquiry has been made to the central competent
authority in accordance with the provisions of the preceding paragraph, it shall
be determined according to the risk level as responded by the central competent
authority.
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.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 analog in blood, urine, or/and stomach contents. This device is to monitor the concentration of
Phencyclidine or Phencyclidine analog in diseases treatment or diagnosis.
A.0002 Clinical Chemistry Electrolyte System 1 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 enzyme in plasma and serum.
A.1025 Adrenocorticotropic hormone (ACTH) test
system2 An adrenocorticotropic 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 t he 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 transferase 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 and for
certain muscle diseases such as progressive Duchenne-type muscular dystrophy.
A.1045 Aldosterone test system 2 An aldosterone test system is a device intended to measure the hormone aldosterone 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,Annexselective 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 group 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 l iver, bone, parathyroid, and intestinal
diseases.
A.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 device that consists of stable isotope internal standards, control materials, extraction solutions,
flow solvents, instrumentation, software packages, and other reagents and materials. The device is intend ed 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 e ach 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 system 1 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- aminolevulinic acid measurements are used in the diagnosis and
treatment of lead poisoning and certain porphyrias (diseases affectin g the liver, gastrointestinal, and nervous
systems that are accompanied by increased urinary excretion 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, and adrenal glands) in serum. An drostenedione 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 an drosterone in 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 system 2 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 ofhypertension.
A.1090 Angiotensin converting enzyme (A.C.E) test
system2 An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of
angiotensin converting enzyme in serum and plasma. Measurements obtaine d 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,
serum, 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 transf erase 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) test system 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. 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 trea tment 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 urine. 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 system 2 The B- type natriuretic peptide (BNP) test system is an in vitro diagnostic 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 device 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 dietary protein bound
vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.
A.1120 Blood gases (PCO2, PO2) and blood pH test 2 A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood,system serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO 2, PO2) 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 increase in erythrocyte mass and total blood volume).
A.1135 C-peptides of proinsulin test system 1 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 of 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 (thyrocalcitonin) levels
in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the
thyroid and parathyroid glands, 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 measur ements
are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease
and tetany (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 used in the determination 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 device 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 detect ion 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 system 2 A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma,
serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of
numerous potentially serious disorders associated with changes in body acid-base balance.
A.1163 Cardiac allograft gene expression profiling test 2 A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA )system expression level 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 system 1 A catecholamines (total) test system is a device intended to determine whether a group of similar compounds
(epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholami ne determinations are
used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-
secreting 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 system 1 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 metabolism disorders.
A.1177 Cholylglycine test system 2 A cholylglycine test system is a device intended to 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 is 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 system 1 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 compound S are used in the diagnosis and treatment of certain adrenal and pituitary
gland disorders resulting in clinical symptoms of masculinization and 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
ofcopper are used 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 the lymph system).A.1195 Corticoids test system 1 A corticoids test system is a device intended to measure the levels of corticoids (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
disorders 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 cortisol
hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis
and treatment of disorders of the 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 diseases and endocrine disorders including hyperthyroidism.
A.1215 Creatine phosphokinase/ creatine kinase or
isoenzymes test system2 A creatine phosphokinase/creatine kinase or i soenzymes test system is a device intended to measure the activity
of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in
plasma and serum. Measurements of creatine phosphokinase and its isoenzymes a re used in the diagnosis and
treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
A.1220 Acute Kidney Injury Test System 2 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 intended to be
used in conjunction with other clinical and diagnostic findings, consistent with professional standard s 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 o f renal diseases, in monitoring renal dialysis, and as a
calculation basis for measuring other 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, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP
measurements may also be used in the dia gnosis and treatment of Graves' disease (a disorder of the thyroid) and
in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)
A.1235 Cyclosporine test system 2 A cyclosporine test system is a device intended to quantitative ly determine cyclosporine concentrations as an
aid in the management of transplant patients receiving therapy with this drug. This generic type of deviceincludes immunoassays and chromatographic assays for cyclosporine.
A.1240 Cystine test system 1 A cys tine 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 dehydroepiandrosterone
(DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosteron e measurements are
used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
A.1250 Desoxycorticosterone test system 1 A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and
urine. DOC m easurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism
(excess retention of sodium and loss of potassium) and other disorders of the adrenal gland.
A.1255 2,3-Diphosphoglyceric acid test system 1 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- diphosphoglyceric 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 device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol
measurements a re 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 pregnant 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 system 1 As estrogens (total, in p regnancy) test system is a device intended to measure total estrogens in plasma, serum,
and urine during pregnancy. The device primarily measures estrone plus estradiol. 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 system 1 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 disorders, 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 system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estronemeasurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea,
differentiation of primary and secondary ovarian 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 metabolic 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 an d treatment of megaloblastic anemia, which is characterized by the
presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
A.1300 Follicle-stimulating hormone test system 1 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 system 1 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 inte nded to measure the acidity of gastric fluid. Measurements of gastric
acidity are 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 used 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 globulins (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 myeloma, and other disorders of blood globulins.
A.1335 Glucagon test system 1 A glucagon test system is a device intended to measure the p ancreatic hormone glucagon in plasma and serum.
Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of
carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.
A.1340 Urinary glucose (nonquantitative) test system 2 A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine).
Urinary glucose (nonquantitative) measurements 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 quantitatively 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, w hich is not a part of the continuous glucose monitor
secondary display, directly receives the glucose data (for example, it communicates directly with transmitter)
from the continuous glucose meter, which is not a part of the continuous glucose monitor sec ondary 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 p erson's continuous glucose monitoring data. A device is not a continuous glucose monitor
secondary display if the data from the primary display device is modified (for example, predicting future 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.1358 Insulin therapy adjustment device 2 An insulin therapy adjustmen t 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 cirrhosisand 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 system 1 A human growth hormone test system is a device intended to measure the levels of human growth hormone in
plasma. Human 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 used 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 measurements are used in the diagnosis and treatment of hereditary histidinemia characterized by
excess histidine in 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 (homosystine in urine), a heritable metabolic disorder which may cause mental
retardation.
A.1380 Hydroxybutyric dehydrogenase test system 1 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 myocardial 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 cortisol, 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 andtreatment of carcinoid tumors of endocrine tissue.
A.1395 17-Hydroxyprogesterone test system 1 A 17-hydroxyprogesterone test system is a device intended to measure 17-h ydroxyprogesterone (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 test 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 Paget's disease, and endocrine disorders such as hyperparathyroidism and
hyperthyroidism.
A.1405 Immunoreactive insulin test system 1 An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and
plasma. Immunoreactive insulin measurements are used 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 hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
A.1415 Iron-binding capacity test system 1 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 system 1 An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme isocitric
dehydrogenase in serum an d plasma. Isocitric dehydrogenase 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 i nsufficiency 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 treatment of disorders of the adrenal cortex and gonads and of other
endocrine disorders, including hypertension, diabetes, and hypothyroidism.
A.1435 Ketones (nonquantitative) test system 1 A ketones (nonquantitative) test system is a device intended to identify 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 fluids) or ketosis (a condition characterized b y increased production of ketone
bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.
A.1440 Lactate dehydrogenase test system 1 A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactatedehydrogenase 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 system 2 A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate
dehydrogenase isoenzymes (a group of enzymes with similar biological activity) 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 to 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-lik e
substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used
in evaluating fetal maturity.
A.1460 Leucine aminopeptidase test system 1 A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-
peptidase in serum, plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and
treatment of liver diseases such as viral hepatitis and obstructive jaundice.
A.1465 Lipase test system 1 Alipase test system is a device 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 system 1 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 system 1 A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme
lysozyme (muramidase) in seru m, plasma, leukocytes, and urine. Lysozyme measurements are used in thediagnosis 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
measurements 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 system 1 A malic dehydro genase test system is a device 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, ca ncer, 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 urine. Mucopolysaccharide 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 identification 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 system 1 A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is
used in the diagnosis and treatment of urinary tract infection of bacterial origin.
A.1515 Nitrogen (amino-nitrogen) test system 1 A nitrogen (amino-nitrogen) test system is a device intended to measure amino ac id nitrogen levels in serum,
plasma, and urine. Nitrogen (amino- nitrogen) measurements are used in the diagnosis and treatment of certain
forms of severe liver disease and renal disorders.
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 system 1 A plasma oncometry test system is a device intended to measure plasma oncotic pressure. Plasma oncotic
pressure is that portion 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 related to low serum protein levels and inc reased capillary permeability,
such as edema and shock.
A.1535 Ornithine carbamyl transferase test system 1 An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine
carbamyl transferase (OCT) in se rum. Ornithine carbamyl transferase measurements are used in the diagnosisand 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 intended 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 used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.
A.1545 Parathyroid hormone test system 2 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 system 1 A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH
are used to evaluate 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 a cid) in serum, plasma,
and urine. Measurements of phenylalanine 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 which, 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
dehydrogenase are used in the diagnosis and treatment of certain liver diseases (such as hepatitis) and anemias.
A.1570 Phosphohexose isomerase test system 1 A phosphohexose isomerase test system is a device intended to measure the activity of the enzyme
phosphohexose 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 cirrh osis, 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 system 1 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 t reatment of various disorders,
including parathyroid gland and kidney diseases, and vitamin D imbalance.
A.1585 Human placental lactogen test system 2 A human placental lactogen test system is a device intended to measure the hormone human placental lactogen
(HPL), (also known as human chorionic somatomammotrophin (HCS)), 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 as sociated 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 porphobilinoge n test system is a device intended to measure porphobilinogen (one of 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 porphyrias (primarily inheri ted 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 hemoglobin, 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 disea ses
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. Measure ments
obtained by this device are used to monitor electrolyte balance in the 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 inten ded to measure pregnanediol (a major urinary metabolic product of
progesterone) 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 Apregnanetriol 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 hyperplasia (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 hormone cortisol 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 system 1 A prolactin (lactogen) test system is a device intended to measur e the anterior pituitary polypeptide hormone
prolactin in serum 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 system 1 A protein (fractionation) test system is a device intended 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 of 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 liver, kidney,
or bone marrow as well as other metabolic or nutritional disorders.
A.1640 Protein-bound iodine test system 1 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 proteins or albumin
in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of
disease conditions such as renal or hea rt 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 blo od cells). Measurements obtained by this device are used in the diagnosis and treatment of
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. Measurement s obtained by this device are used in the evaluation of
electrolyte metabolism and in the diagnosis and treatment of electrolyte disturbances or ano xia (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 medical purposes for use in a test system to estimate test precision and to detect systematic analytical
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 includescontrols (assayed and unassayed) 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 in interlaboratory 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. Measurements
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 hypertension, 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 system 1 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 treatme nt of liver
disorders such as cirrhosis or acute hepatitis.
A.1675 Blood specimen collection device 2 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.
A.1678 Tacrolimus test system 2 A tacrolimus test system is a device intended to quantitatively 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 chromatographic 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 hor mones (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 system 2 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 diagnosis and treatment of thyroid diseases.
A.1690 Thyroid stimulating hormone test system 2 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 stimulatinghormone 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 d evice 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 met abolic status of thyroxine. Measurements
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, other diseases involving lipid metabolism, or various endocrine disorders.
A.1710 Total triiodothyronine test system 1 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 system 1 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- binding
prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine
levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of
thyroid disorders.
A.1720 Triose phosphate isomerase test system 1 A triose phosphate isomerase test system is a device intended to measure the activity of the enzyme triose
phosphate isomerase 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 of 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
this 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 ofphenylalanine in detecting congenital phenylketonuria (a disease 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 the
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 system 1 A urinary calculi (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 urobilinogen (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 treatment 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 used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with
disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme
pathway.
A.1795 Vanilmandelic acid test system 1 Avanilmandelic acid test system is a device intended to measure 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 intestinal 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 this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (agroup of disorders in which 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- hydroxyvitamin 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 use 1 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 device 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 inten ded 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, preparing filtrates, heating, and
measuring color intensity. This device is intended for use in conjunction with certain materials to measure a
variety of analytes. Differen t models of the device incorporate various 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 use 1 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 distinguishing characteristic of the device is that it requires only micro volume samples obtainable
from pediatric patients. This device is intended for use in conjunction with certain mater ials 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 device may i nclude accessories such as columns, gases, column supports, and liquidcoating.
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) through 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, measur e and sort signals in order to analyze nucleic acid sequences in a clinical sample. The 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 use 1 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 are useful in the diagnosis and treatment of various disorders.
A.2400 Densitometer/scanner (integrating, reflectance,
TLC, or radiochromatogram) for clinical use1 A densitometer/scanner (integrating, reflectance, thin- layer chromatography, or radiochromatogram) 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 measu rement of the light transmission through a given area of the medium or, in the case
of the radiochromatogram scanner, by measurement of the distribution of a specific radio- active element on a
radiochromatogram.
A.2485 Electrophoresis apparatus for clinical use 1 An electrophoresis apparatus for clinical use is a device intended to separate molecules 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 use 1 An enzyme analyzer for clinical use is a device intended to measure enzyme s in plasma or serum by nonkinetic
or kinetic measurement of enzyme- catalyzed reactions. This device is used in conjunction with certain materialsto 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 use 1 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 concentratio n of these
substances in the body are indicative of certain 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 establish a single indicator to aid in diagnosis. Such instrumentation may be
compatible with more than one specific assay. The device includes a signal reader uni t, 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 use 1 A nephelometer for clinical use is a device intended to estimate the concentration 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 conjunction with certain materials to measure the concentration of a variety of analytes.
A.2720 Plasma oncometer for clinical use 1 A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is th at
portion of the total 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 pressure required to p revent the passage of a solution with a lesser solute concentration into a
solution with greater solute concentration when the two solutions are separated by a semipermeable membrane.
The concentration of a solution affects its osmotic pressure, freezing p oint, and other physiochemical properties.
Osmometers determine osmotic pressure by methods such as the measurement of the freezing point.
Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.
A.2800 Refractometer for clinical use 1 A refractometer for clinical use is a device intended to determine the amount 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 solu tion). The
index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteinsand 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 identi fied according to the
wavelength and intensity of the light 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 use 1 A mass spectrometer for clinical use is a device intended to identify inorganic or organic 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 system 1 An automated urinalysis system is a device intended to measure certain of the physical properties and chemical
constituents of urine by proc edures that duplicate manual urinalysis systems. This device is used in conjunction
with certain materials to measure a variety of urinary analytes.
A.2920 Plasma viscometer for clinical use 1 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 through a calibrated glass tube. Measurements
obtained by this device are used to monitor changes in the amount of solids present in plasma i n various
disorders.
A.3030 Acetaminophen tests system 2 An acetaminophen test system is a device intended to measure acetaminophen, an analgesic and fever reducing
drug, in serum. Measurements obtained by this device are used in the diagnosis and treatme nt 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 treatm ent 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 alcohol intoxication and poisoning.
A.3050 Breath-alcohol test system 1 A breath-alcohol test system is a device intended to measure alc ohol in the human breath. Measurements
obtained by this device are used in the diagnosis of alcohol intoxication.
A.3080 Breath nitric oxide test system 2 A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath.
Measurement of changes 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 assessmentsof asthma. A breath nit ric oxide test system combines chemiluminescence 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 treatment 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 contents. 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 contents, 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 tr eatment
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, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used
in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines
to ensure appropriate therapy.
A.3200 Clinical toxicology calibrator 2 A clinical to xicology calibrator is a device intended for medical purposes for use in a test system to establish
points of reference that are used in the determination of values in the measurement of substances in human
specimens. A clinical toxicology calibrator can b e a mixture of drugs or a specific material for a particular drug
(e.g., ethanol, lidocaine, etc.).
A.3220 Carbon monoxide test system 1 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 system is a device inte nded 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 cholinesterase 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 treatment of cholinesterase inhibition
disorders (e.g., insecticide poisoning, and succinylcholine poisoning).
A.3250 Cocaine and cocaine metabolite test system 2 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 drug) 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 codeine to ensure appropriate therapy.
A.3300 Digitoxin test system 2 A digitoxin test system is a device intended t o 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 to 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 obtained 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 system 2 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 the diagnosis and t reatment 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 d eoxyribonucleic acid
(DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding
a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing
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, 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.3450 Gentamicin test system 2 A gentamicin test syste m 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 kanamycin overdose and inmonitoring 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 device 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 antiarrythmic 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.3560 Lithium test system 2 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).
A.3580 Lysergic acid diethylamide (LSD) test system 2 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.
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 system 2 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 meth aqualone, 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 d iagnosis and
treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate
therapy.
A.3652 Organophosphate test system 2 An organophosphate test system is a device intended to measure organophosphate metab olites quantitatively in
human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data
obtained by this device is intended 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 diagnosis 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 antiepileptic 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 to 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 intended to quantitative ly 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 intended to measure sulfona mides, 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-
tetrahydrocanna binol, 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
obtained by this device ar e used in the 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 system 2 A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant
drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline,
protriptyline, and doxep in. 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 ensure 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 system 2 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) Automatic blood component extractors including sensors, weighting devices, are Class 2
devices; (2) Other devices are Class 1 devices.
B.1850 Dye and chemical solution stains 1 Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye
chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or
hematology.
B.1860 Immunohistochemistry reagents and kits 1,2, 3 Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal 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
toprovide 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 informatio n 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 receptors 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 limited 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 secti ons. This device is not intended to detect the presence
of HPV .
B.1866 Lynch Syndrome test systems 2 Lynch syndrome test systems are in vitro diagnostic tests for use with tumor tissue to identify previously
diagnosed cancer patients 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 and 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 cells 1 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 components 1 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 formulations 1 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 most 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
intended as an aid to the pathologist to review and interpret digital images of surgical 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) Cla ss 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 test intended 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 outcomeand 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-au tomated 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 hematoc rit 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.5220 Automated differential cell counter 2 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, c ount, 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 desig nation) markers.
The device includes accessory CD markers.
B.5240 Automated blood cell diluting apparatus 1 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 device 2 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, such as the arm.)
B.5300 Red cell indices device 2 A red cell indices device, usually 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 cell indices are used for the differential diagnosis of anemias.
B.5350 Microsedimentation centrifuge 1 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 semiautomated device used to determine the onset of clot formationfor 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 coagula tion studies
and coagulation factor assays.
B.5600 Automated hematocrit instrument 2 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 system 2 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 instrumentation
used to determine the hemoglobin content of human blood.
B.5680 Automated heparin analyzer 2 An automat ed 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 t he amount of protamine necessary to neutralize the heparin in
the patient's circulation.
B.5700 Automated platelet aggregation system 2 An automated 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 device 1 An automated sedimentation 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 device 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 device 2 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, primarily the platelets.
B.6150 Capillary blood collection tube 1 A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood
by capillary action.
B.6160 Manual blood cell counting device 1 A manual blood cell counting device is a device used to count red blood ce lls, white blood cells, or blood
platelets.B.6400 Hematocrit measuring device 1 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 bloo d 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 high total red cell mass). The packed red cell volume is produced b y 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 small 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 to 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 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.6700 Erythrocyte sedimentation rate test 1 An erythrocyte sedimentation rate test is a device that 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 increased 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 distribution 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
pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
B.7040 Adenosine triphosphate release assay 1 An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate (ATP)
from platelets 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
administration of heparin in the treatment of thrombosis. The de termination may also be used in the diagnosis
of thrombophilia (a congenital deficiency of antithrombin III).
B.7100 Red blood cell enzyme assay 2 Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically import antenzymatic 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 tests 2 An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of
venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.
B.7250 Erythropoietin assay 2 Aerythropoietin 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 information 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 formed from fibrinogen in the euglobulin fraction (that fraction o f the plasma responsible for the formation
of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after
bleeding has been arrested). The test also will detect 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 reaction (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 deficiency test is a device used to diagnose specific coag ulation 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 deficiency such as hemophilia and the corresponding normal gene).
B.7300 Fibrin monomer paracoagulation test 2 A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated
intravascular coagulation (nonlocalized clotting within 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 assay 2 A fibrinogen/fibrin degradation products 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 fibrinolysi s
(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 system 2 A fibrinogen 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 2 An erythrocytic glucose-6- phosphate dehydrogenase assay is a device used to measure the activity of the enzymedehydrogenase assay glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydroge nase 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 deficiency. This generic device
includes a ssays 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 the activity of the enzyme glutathione r eductase in
serum, plasma, or erythrocytes 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 decreased 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 isolate 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 an 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 system 2 An electrophoretic hemoglobin analysis system is a device that electrop horetically 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.
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 t he elevated levels of fetal hemoglobin exhibited in
cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a
decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determina tion
may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial
immunodiffusion.
B.7470 Glycosylated hemoglobin assay 2 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 insulin 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 compoun d 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 be made using methods such as spectroscop y, colorimetry,
spectrophotometry, or gasometry.
B.7500 Whole blood hemoglobin assays 2 A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or
spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of
anemia. This generic device category does not include automated hemoglobin systems.
B.7525 Heparin assay 2 A heparin assay is a device used to determine the level of the anticoagulant heparin in the p atient's circulation.
These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor
X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that
neutralizes heparin).
B.7660 Leukocyte alkaline phosphatase test 1 A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in
neutrophilic granulocytes (granular leukocytes stainable 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 chronic granulocytic leukemia (a malignant 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 tes t is a device used to distinguish certain myeloid cells derived from the bone marrow,
i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells
of the red blood cell series base on their peroxidase activ ity as evidenced by staining. The results of this test are
used in the differential diagnosis of the leukemias.
B.7695 Platelet factor 4 radioimmunoassay 2 A platelet factor 4 radioimmunoassay is a device used to measure the level 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 test 2 Aprothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in
the coagulation 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 thrombo 2 The prothrombin- proconvertin test and thrombotest are devices used in the regulation of coumarin therapytest (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 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.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 test 1 A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and
coagulation inhibitors.
B.7925 Partial thromboplastin time tests 2 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.
B.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 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.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 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.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 counting 2 A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used
to set a plat elet counting instrument. It is a suspension of particles or cells whose size, shape concentration, andother characteristics have been precisely and accurately determined.
B.8185 Calibrator for red cell and white cell counting 2 A calibrator for red cell and 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 medium 1 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 counting of white blood cells.
B.8625 Hematology quality control mixture 2 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 cou nt
(RBC), platelet 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 includes products such as blood bank pipettes, blood grouping slides, blood typ ing 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 collect ion and processing 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 further processing.
B.9125 Vacuum-assisted blood collection system 1 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 blood 2 A processing system for f rozen 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 software 2 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 identification 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 withBECS 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 device 2,3 (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 electromagnetic 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 separator 2 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, and return to the donor the remainder of the whole blood and blood
component s. The remainder of blood components is 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 device used to separate and prepare cells
and sera for further in vitro diagnostic testing.
B.9300 Automated Coombs test systems 2 An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies
bound to red cells. 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 milliliters of bloodfor 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 cells with certain 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 p roteins derived from plants and lower animals 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 use 1 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 reagents 2 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 refri gerator and a blood storage freezer are devices intended 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 bags 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 transfer 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 blood. This device is a functionally closed processing system that includes containers, 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 reagents 2 Enterovirus 71 serological reagents are devices that consist of antigens and antisera used to detect serum
enterovirus antibodies in serological tests. Additionally, some of these reagents consist of enterovirus antisera
conjugated with a fluorescent dye w hich used to detect enterovirus from clinical specimens or from cultured
isolates derived from clinical specimens. The identification aids in the diagnosis of enterovirus infections and
provides epidemiological information on diseases caused by these virus es. Enterovirus cause illnesses such ashand, foot and mouth diseases which in its serious form affect the central nervous system resulting in
encephalitis, viral meningitis or/and paralysis.
C.0002 Dengue virus serological reagents 2 Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of dengue
antibodies in serological tests. This detection aids in diagnosis of diseases caused by dengue virus and provides
epidemiological information on diseases caused by these viruses. These diseases are transmitted by mosquitos.
The symptoms of these are like influenza including fever, fatigue, cough, and headache. The worst symptom is
dengue hemorrhagic fever or dengue shock syndrome.
C.0003 Helicobacter spp. serological reagents 1 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 isolates 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, stomach inflammation (gastritis) leading to upper abdominal pain and bleeding.
C.0004 Human papillomavirus serological reagents 3 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 status of patients, and provides epidemiological information on diseases caused by
these viruses.
C.0005 Plasmodium spp. serological reagents 2 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, which 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 test disc 2 An antimicrobial susceptibility test disc is a device that consists of antimicrobic- impregnated paper discs used
to measure by a 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 susceptib ility 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 powder 2 An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packagedin 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 into 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 of 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 performed 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 actio n of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are
used primarily as an aid in the diagnosis of disease 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 colonies 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 sy stem 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 phenotypic and morphologic characteristics through analysis of two- dimensional digital
images as an aid in diagnosis of infectious disease.
C.2300 Multipurpose culture medium 1 A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended
for med ical purposes for the cultivation and identification of several types of pathogenic microorganisms without
the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide
epidemiological information on diseases 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 purposes 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 also provides epidemiologic al
information on these diseases.
C.2350 Microbiological assay culture medium 1 A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials
intended for medical purposes to cultivate selected test microorganisms 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 these substances is measured by their ability to pr omote 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 purposes to cultivate and iden tify 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 ca used 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 viabi lity 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 these diseases.
C.2410 Culture medium for pathogenic Neisseria spp 2 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 identification 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 gonorrhea 3 An oxidase screening test for gonorrhea is an in vitro device that consists of the articles intended to identify by
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is associated with certain bacteria includingNeisseria 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 thi s device indicates presumptive infection of the patient with the
causative agent of gonorrhea.
C.2450 Supplement for culture media 1 A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid
basal culture medium to produce 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 media 1 A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each
impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to 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 device 1 A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or
serially dilute 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 propert ies, optical density, electrical
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 purp oses that produces predetermined 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 diagnosis 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 more 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 todifferentiate and identify selected microorganisms. 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 antimicrobial susceptibility tests. The device aids in decision making respecting the
treatment of disease.
C.2900 Microbiological specimen collection and
transport device1 A microbiological sp ecimen 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 during their transport from t he 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 of disease caused by the bacterium Acinetobacter calcoaceticus 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 result in sepsis (blood poisoning).
C.3020 Adenovirus serological reagents 1 Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies 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
onthese 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 reagents 1 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 ep idemiological information on diseases caused by
these microorganisms. Arizona spp. can cause gastroenteritis (food poisoning) and sepsis (blood poisoning).
C.3040 Aspergillus spp. serological reagents 1 Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various 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.3050 Beta-glucan serological assays. 2 Beta-glucan sero logical assays are devices that consist of antigens or proteases used in serological assays. The
device is intended for use for the presumptive diagnosis of fungal infection. The assay is indicated for use in
patients with symptoms of, or medical condition s 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 reagents 1 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 reagents 1 Bordetella spp. se rological 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 respira tory infections
characterized by pneumonitis (inflammation of the lungs).
C.3085 Brucella spp. serological reagents 1 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 s pp. directly from clinical specimens or cultured
isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant
fever, Malta fever) caused by bacteria belonging to the genus Brucella and provides epidemiol ogical information
on diseases caused by these microorganisms.
C.3110 Campylobacter fetus serological reagents 1 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 reagents 1 Chlamydia serological r eagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera
conjugated with a fluorescent dye used to identify chlamydi a directly from clinical specimens or cultured isolatesderived 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. Chl amydia 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 reagents 1 Citrobacter spp. serological reagents are devices that consist of antigens and antisera used in serological tests to
identify Citrobacter spp. from cultured isolates derived 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 Clos tridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification
and detection of target sequences in Clostridium difficile toxin genes in fecal specimens from patients suspected
of having Clostridium difficile i nfection (CDI). The detection of clostridial toxin genes, in conjunction with
other laboratory tests, aids in the clinical laboratory diagnosis of CDI caused by Clostridium difficile.
C.3135 Coccidioides immitis serological reagents 1 Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological
tests to identify antibodies to Coccidioides immitis 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 produces
symptoms varying in severity from those accompanying the common cold to those of influenza.
C.3140 Corynebacterium spp. serological reagents 1 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 diagn osis of disease
caused by bacteria belonging to the genus Corynebacterium and provides epidemiological information on
diseases caused by these microorganisms. 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 nonpathogenic or have an uncertain
role.
C.3145 Coxsackievirus serological reagents 1 Coxsackievirus serological reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies to coxsackievirus in serum. Additionally, some of these reagents consist of coxsackievirus
antisera conjugated with a fluorescent dye th at are used to identify coxsackievirus from clinical specimens or
from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of
coxsackievirus infections and provides epidemiological information on diseases cause d by these viruses.
Coxsackieviruses produce a variety of infections, including common colds, meningitis (inflammation of brainand spinal cord membranes), herpangina (brief fever accompanied by ulcerated lesions of the throat), and
myopericarditis (inflammation of heart tissue).
C.3165 Cryptococcus neoformans serological reagents 1 Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to
identify antibodies to Cryptococcus neoformans in serum. Additionally, some of these reagents consist of
antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus
neoformans directly from clinical specimens or from cultured isolates derived from clinical specim ens. The
identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of
disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain
membranes) and, if not treated, are usually fatal.
C.3175 Cytomegalovirus serological reagents 2 Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological 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. Cytomegalic 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 disability, and mental retardation. Cytomegalovirus
infection has also been associated with acq uired hemolytic anemia, acute and chronic hepatitis, and an infectious
mononucleosis-like syndrome.
C.3200 Echinococcus spp. serological reagents 1 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 d isease. 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 reagents 1 Echovirus serological reagents are devices that consi st of antigens and antisera used in serological tests to
identify antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera
conjugated with a fluorescent dye used to identify echoviruses from clinical specimens or from tissue culture
isolates derived from clinical specimens. The identification aids in the diagnosis of echovirus infections and
provides epidemiological information on diseases caused by these viruses. Echoviruses cause illnesses such as
meningitis (in flammation 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 assessmentof 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 a nd/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 reagents 1 Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological
tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of th ese reagents consist of
antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica
directly from clinical specimens. 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 assay 2 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 vi ral meningitis
caused by enterovirus.
C.3235 Epstein-Barr virus serological reagents 1,2 Epstein- Barr virus serological reagents are devices that consist of antigens 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 Bu rkitt'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 epidemiological 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 brain), rash, acute arthritis, or hepatitis.
C.3250 Erysipelothrix rhusiopathiae serological 1 Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used inreagents serological tests to identify Erysipelothrix rhusiopathiae from cultured isolates derived from clinical 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 reagents 1 Escherichia coli sero logical 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 identification 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 microorganisms 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 reagents 1 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 disease caused by bacteria belonging to the genus Flavobacterium and provides
epidemiological inf ormation 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 ca use epidemics of septicemia (blood
poisoning) and meningitis (inflammation of the membranes of the brain) and is usually attributable to
contaminated hospital equipment.
C.3280 Francisella tularensis serological reagents 1 Francisella tularensis serologic al reagents are devices that consist of antigens and antisera used in serological
tests to identify antibodies to Francisella tularensis in serum or to identify Francisella 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
specimens. The identification aids in the diagnosis of tularemia caused by Francisella tula rensis and provides
epidemiological information on this disease. Tularemia is a di sease principally of rodents, but may be transmitted
to humans through handling of infected 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 gonococcal antibody test (GAT) is an in vitro device that consists of the reagents intended to identify byimmunochemical 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 reagents 1 Haemophilus spp. serological reagents 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 clinical 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.
include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, an d a contagious form of
conjunctivitis (inflammation of eyelid membranes).
C.3305 Herpes simplex virus serological reagents 2,3 Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various
serological tests to i dentify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist
of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify
herpes simplex virus directly from clinical specime ns or tissue culture isolates derived from clinical specimens.
The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides
epidemiological information on these diseases. Herpes simplex viral infections range from comm on 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 devi ces 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 lesion samples from symptomatic patients suspected of Herpetic infections. Negat ive results do
not preclude infection and should not be used as the sole basis for treatment or other patient management
decisions. The assay is not intended for use in cerebrospinal fluid samples.
C.3320 Histoplasma capsulatum serological reagents 1 Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological
tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of
Histoplasma capsulatum antise ra conjugated with a fluorescent dye (immunofluorescent reagents) used to
identify Histoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens.
The 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. Histoplasmosisusually is a mild and often asymptomatic respiratory 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 system 2 An influenza virus antigen detection test system is a device for qualitative (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 to
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 reagents 1 Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides
epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often
epidemic. This classification does not include devices for qualitative (rapid screening) detection of influenza
virus infection directly from clinical specimens of patients with respiratory 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 f or 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 of 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 epidemiological information on influenza. These
reagents include primers, probes, and specific influenza A virus controls.
C.3336 John Cunningham Virus serological reagents 2 John Cunningham Virus serological reagents are devices that consist of antigens and antisera used in serological
assays to identify antibodies to John Cunningham Virus in serum and plasma. The identification aids in the risk
stratification for the development of progressive multifocal leukoencephalopathy in multiple sclerosis and
Crohn's disease patients undergoing natalizumab therapy. These devices are for adjunctive use, in th e context of
other clinical risk factors for the development of progressive multifocal leukoencephalopathy.
C.3340 Klebsiella spp. serological reagents 1 Klebsiella spp. serological reagents are devices that consist of antigens and antisera, including ant isera
conjugated with a fluorescent dye (immunofluorescent reagents), that are used in serological tests to identify
Klebsiella spp. from cultured isolates derived 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 reagents 1 Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests toidentify antibodies to Leptospira spp. in serum or identify Leptospira spp. from cultured isolates derived from
clinical specimens. Addit ionally, 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 reagents 1 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 reagen ts
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, causes
meningitis (inflammation of the brain membranes) and meningoenceph alitis (inflammation of the brain and brain
membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in
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 to identify 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 choriomeningitis viruses usually cause a mild cerebral meningitis
(inflammat ion 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
cultures is a qualitative in vitro device intended to simultaneously d etect and identify microorganism nucleic
acids from blood cultures that 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 Mycobacterium tuberculosis directly from clinical specimens. The identificati on
aids in the diagnosis of tuberculosis and provides epidemiological information on this disease. Mycobacteriumtuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized
by formation of tubercles (smal l 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
Mycobacterium tuberculosis complex nucleic acids extracted from human resp iratory 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 findings. These devices do not include devices intended to detect
the presence of organism mutations associated with drug resistance. Respiratory specimens may include 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 r esults. 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.3375 Mycoplasma spp. serological reagents 1 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 pneu moniae range from
inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.
C.3380 Mumps virus serological reagents 1 Mumps virus serological reagents consist of antigens and antisera used in serological tes ts to identify antibodies
to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent
dye (immunofluorescent reagents) 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 epidemiologicalinformation on mumps. Mumps is an acute contagious disease, particularly in children, characterized 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 reagents 2 Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serologic al
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. di rectly 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
disease, and gonorrhea, and also provides epidemiological info rmation 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 reagents 2 Norovirus serological reagents are devices that consist of antigens and antisera used in serological tests to detect
the presence 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 symptoms of acute gastroenteritis and/or aid in the identification
of norovirus as the etiology of an o utbreak of acute gastroenteritis in the setting of epidemiologically linked
patients with symptoms of acute gastroenteritis.
C.3400 Parainfluenza virus serological reagents 1 Parainfluenza virus serological reagents are devices that consist of antigens an d antisera used in serological tests
to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza
virus infections and provides epidemiological information on diseases caused by these viruses. Parainflue nza
viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.
C.3402 Plasmodium species antigen detection assays 2 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 malar ia infection. The detection of these antigens aids in the clinical laboratory
diagnosis of malaria caused by the four malaria species capable of 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 reagents 1 Poliovirus serolo gical reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antiseraconjugated with a fluorescent dye (immunofluoresce nt reagents) used to identify polioviruses from clinical
specimens or from tissue culture isolates derived from 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 resulting in atrophy (wasting
away) of groups of muscles, ending in contraction and permanent deformity.
C.3410 Proteus spp. (Weil-Felix) serological reagents 1 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 specific type 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 reagents 1 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. f rom
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 infect ions, and has been associated with urinary tract infections, eye infections,
burn and wound infections, blood poisoning, abscesses, and meningitis (inflammation of brain membranes).
Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.
C.3460 Rabiesvirus immunofluorescent reagents 2 Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a
fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identificat ion
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 central 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 reagents 1 Reovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify
antibodies to reovirus in serum. The identification aids in the diagnosis of reovirus infections and provides
epidemiological information on diseases caused by these viruses. Reoviruses are thought to cause only mild
respiratory and gastrointestinal illnesses.
C.3480 Respiratory syncytial virus serological reagents 1 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, some of these
reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescentreagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates
derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections
and provides epidemiologic al information on diseases caused by these viruses. Respiratory syncytial viruses
cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile
bronchopneumonia.
C.3490 Rhinovirus serological reagents 1 Rhinovirus serological reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies 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 reagents 1 Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to
identify antibodies to rickettsia in s erum. Additionally, some of these reagents consist of rickettsial antisera
conjugated with a fluorescent dye (immunofluorescent reagents) 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 humans characterized by rash
and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
C.3510 Rubella virus serological reagents 2 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 reagents 1 Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological
tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and
provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the
respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.
C.3550 Salmonella spp. serological reagents 1 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 salmonellosis caused by bacteria belonging to the genus Salmonella and provides epidemiological
information on this disease. Salmon ellosis is characterized by high grade fever ("enteric fever"), severe diarrhea,
and cramps.
C.3600 Schistosoma spp. serological reagents 1 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 schistosomiasiscaused by parasitic flatworms of the genus Schistosoma. Schistosomiasis is characterized by a variety of acute
and chronic infections. Acute in fection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are
usually severe and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver,
lungs, and central nervous system. Schistosomes can also cause schistosome dermatitis (e.g., swimmer's itch), a
skin disease marked by intense itching.
C.3630 Serratia spp. serological reagents 1 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 reagents 1 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. Shig ellosis is characterized by abdominal
pain, cramps, diarrhea, and fever.
C.3680 Sporothrix schenckii serological reagents 1 Sporothrix schenckii 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 reagents 1 Staphylococcus aureus serological reagents are devices 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 diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus
and provides epidemiological information on these diseases. Certain strains of Sta phylococcus 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 reagents 1 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 epid emiological information on these diseases. Pathogenic streptococci are
associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the
skin), urinary tract infections, rheumatic fever, and kidney disease.
C.3740 Streptococcus spp. serological reagents 1 Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal
exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus 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. Pathog enic streptococci are associated with infections, 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 reagents 2 Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests
to identify 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 dise ase. Congenital toxoplasmosis is
characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain
defects, blindness, 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 of 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 reagents 2 Treponema pallidum treponemal test reagents are devices that con sist of the antigens, antisera and all control
reagents (standardized reagents with which test results are compared), and is used in serologic tests to identify
the reactive element, an antibodies-like substance, produced by the action of the syphilis orga nism with human
tissue. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema
and provides epidemiological information on syphilis.
C.3850 Trichinella spiralis serological reagents 1 Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests
to identify 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 ingestion of undercooked, infested meat, especially pork, and characterized
by fever, muscle weakness, and diarrhea.
C.3860 Trichomonas vaginalis nucleic acid assay 2 A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls
for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, andfemale urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the
diagnosis of trichomoniasis 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 reagents 1 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 parasitic 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 seriousl y affects the central nervous
system and heart muscle.
C.3900 Varicella-zoster virus serological reagents 2 Varicella- zoster virus 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 p resent in latent form
in the patient's body.
C.3930 Vibrio cholerae serological reagents 1 Vibrio cholerae serological reagents are devices that are used in the agglutination (an antigen- antibody clumping
reaction) test to identify Vibrio cholerae from cu ltured isolates derived from clinical specimens. The
identification aids in the diagnosis of cholera caused by the bacterium Vibrio 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 reagents 2 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/enceph alitis. The detection aids in the clinical laboratory diagnosis of viral
meningitis/encephalitis caused by West Nile virus.
C.3946 Dengue virus nucleic acid amplification test
reagents2 Dengue virus nucleic acid amplification test reagents are devices th at consist of primers, probes, enzymes, and
controls for the 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). The identification of dengue virus serotypes 1, 2, 3, or 4 in human serum and plasma (sodium
citrate) collected from human patients with dengue 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 based 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 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 encephalitis. 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 laboratory 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 from 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
conjunction with other clinical and laboratory findings. The device is intended for detection and identification
of a combination of the following viruse s:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and
Influenza A subtype H3; (3)Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapne umovirus; (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 m arker nucleic acids directly from
respiratory specimens is an in vitro diagnostic device intended for the detection and identification of
microorganisms and associated resistance markers in respiratory specimens collected from patients with signs
or sympto ms of respiratory infection. The device is intended to aid in the diagnosis of respiratory infection in
conjunction 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 by
the device.
C.3990 Gastrointestinal microorganism multiplex
nucleic acid-based assay2 A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device
intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from
human stool specimens. The device detects specific nucleic acid sequences for organism identification as wellas for determini ng the presence of toxin genes. The detection and identification of a specific gastrointestinal
microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the
diagnosis of gastrointestinal infection when use d in conjunction with clinical 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 specimens, 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 complemen t, 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 equipment 1 Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating
protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an
agar gel and the various proteins are separated on the ba sis of their relative mobilities under the influence of an
electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific
antiserum, allowing precipitation and visualization of the separate complexes.
C.4520 Immunofluorometer equipment 1 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 measur ed 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 pho todetector, 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 equipment 1 Immunonephelometer equipment for 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 scattered by the particles in suspension. The
amount of light is detected by a photodetector, which converts light energy into electr ical 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- antibodycomplexes . 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. In immunodiffusion, 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 matrix and is immobilized.
C.4700 Automated fluorescence in situ hybridization
(FISH) enumeration systems.2 An automated FISH enumeration 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, counting and classification of cells based on
recognition of cellular color, size, and shape, and in the detection and enumeratio n 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 is 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
processor, or other hardware components. The software may include fluorescent signal acquisition and
processing softwar e, data storage and transferring mechanisms, or assay specific algorithms to suggest results.
A trained operator must confirm results generated with the device.
C.4800 Radial immunodiffusion plate 1 A radial immunodiffusion plate for clinical use is a dev ice that consists of a plastic plate to which agar gel
containing antiserum is added. In radial immunodiffusion, antigens migrate through gel which originally
contains specific antibodies. As the reagents come in contact with each other, they combine to fo rm a precipitate
that is trapped in the gel matrix and immobilized.
C.4830 Rocket immunoelectrophoresis equipment 1 Rocket immunoelectrophoresis 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 migrate throu gh 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 system 1 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 system 1 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 devi ce 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 device 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 (a ntibodies 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 i mmunological 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 nucle us of a cell, such as ribonucleic acid,
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
(aliver 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 immunological 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 cell s located in the stomach that 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 conn ective 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 r eagents 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 theliver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's
own tissues).
C.5130 Alpha-1-antitrypsin immunological test system 2 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 cancerous 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 uri ne 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 (in creased 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 system 1 A beta-globulin immunological test system is a device that consists 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 system 1 A breast milk immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the breast milk proteins.
C.5180 Fecal calprotectin immunological test system 2 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 colitis, 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.
Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.C.5210 Ceruloplasmin immunological test system 2 A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by
immunochemical 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 system 1 A Cohn fraction 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 use d as a coprecipitant in radioimmunoassay 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 system 1 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 A complement components immunological 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 tis sues. Complement is a group of serum proteins 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)
immunological test system2 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 normally 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 ed ema (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 Acomplement C3binactivator immunological test system is a device that consists of the 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 C3bin activator aids in the
diagnosis of inherited antibody dysfunction.
C.5270 C-reactive protein immunological test system 2 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 system 1 A properdin factor B immunological test system is a device that consists of the reagents used 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 s erum 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 system 1 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 system 2 A ferritin immunological 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 system 2 A fibrinopeptide A immunological test system is a device that consists of the reage nts 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 system 1 A Cohn fraction 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 affecting the 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 system 1 A Cohn fraction V immunological test system is a device that consists of or measures that fraction of plasma
containing predomin antly 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 intestine), 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 secre tory component (normally a portion of the secretory IgA antibody
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 system 1 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 syst em is a device that consists of the reagents used to measure 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 collagen (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 cancers 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 consi sts 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 othe r 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 system 1 A haptoglobin immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen- carrying pigment in
red blood cells) in serum. Measurement of haptog lobin may aid in the diagnosis of hemolytic diseases (diseases
in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin- haptoglobin
complexes and certain kidney diseases.
C.5470 Hemoglobin immunological test system 2 A hemoglobin immunological test system is a device that consists of the reagents used to measure byimmunochemical techniques the different types of free hemoglobin (the oxygen- carrying pigment in red blood
cells) in blood, urine, plasma, or other bod y 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 system 1 A hemopexin immunological test 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 disorders, 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 tec hniques the immunoglobulin antibodies in serum which react specifically with
organic dust derived from fungal or animal protein sources. When these antibodies react with such dusts in the
lung, immune complexes precipitate and trigger an inflammatory react ion (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 Animmunoglobulins 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 i n 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 measure 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
immunoglob ulin 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 (c arbohydrate 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) 1 An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagentsimmunological test system used to measure by immunochemical techniques the amino terminal (antigen- binding) end (Fd fragment) of the
heavy chain (a subunit) of the 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 chain specific)
immunological test system2 An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents
used to measure by immunochemical techniques both kap pa 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 Alactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by
immunochemical 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 l imited because of the many conditions
known to cause increased lactic dehydrogenase levels.
C.5570 Lactoferrin immunological test system 1 A lactoferrin immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the lactoferrin (an iron- binding protein with the ability to inhibit the growth of
bacteria) in serum, breast 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 system 2 An alpha-1- lipoprotein immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and p lasma.
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 system 1 A lipoprotein X immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques 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 measure
by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement oflow-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, and other 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 device 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. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune 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 measure
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 to
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 clinical and laboratory findings.
C.5680 Myoglobin immunological test system 2 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 plasmaor 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 system 1 A plasminogen immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques 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 system 1 A prothrombin immunological test system is a device that consists of the reagents used to measure by
immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of
antigenically 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 of 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
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.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
immunochemical 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 system 2 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 tissues. 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 th at reactwith 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 SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).
C.5830 Brain trauma assessment test 2 A brain trauma assessment test is a device that consists of reagents used to detect and measure brain injury
biomarkers 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 system 1 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 autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's
disease (chronic lymphocytic thyroiditis), nontoxic goiter (en largement of thyroid gland), Grave's disease
(enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.
C.5880 Transferrin immunological test system 2 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 malnutrition, 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 the 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 variants in the CFTR gene. It is intended 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 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 ai d
in screening newborns for SCID. Presumptive positive results must be followed up by diagnostic confirmatorytesting. This test is not intended for use as a diagnostic test, or for screening of SCID- like syndromes, such as
DiGeorge syndrome or Omenn syndr ome. 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 system 2 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'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 residual 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 diseas e 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 hepatocellular carcinoma, i n 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 prognosis 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 isplanned, is maligna nt. The test is for adjunctive 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 Anext 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 the 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 1 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.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 pa rtial pressure of carbon dioxide
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 2
transducer (e.g., PO 2electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood toaid 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 analyzer 2 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 e nflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas
mixture.
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 device may use techniques such as mass spect rometry 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 device 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 determining a patient's ventilatory status. The device may use te chniques 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 includes 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 meter 2 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 differential 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 patient's lungs.
D.1850 Monitoring spirometer 2 Amonitoring spirometer is a device used to measure continuously a patient'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 spirometry 2 A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.
D.1880 Pulmonary-function data calculator 2 A pulmonary-function data calculator is a device used to calculate pulmonary- function values based on actual
physical data obtained during pulmonary-function testing.
D.1890 Predictive pulmonary-function value calculator 2 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 esophageal 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 physiological sounds.
D.1975 Water vapor analyzer 1 A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired
gases by using techniques such as mass spectrometry.
D.2025 Ultrasonic air embolism monitor 2 An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may useDoppler 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 resp iratory
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 flowmeter 1 An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and
control gas flow 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 flowmeter 1 A compensated th orpe tube flowmeter is a device intended for medical purposes that is used 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 monitor 2 A breathing (ventilatory) frequency monitor is a device 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 detected 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 me asure the concentration of nitric oxide in respiratory gas
mixtures during 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 mixtures 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 in thoracic electrical impedance (resistance to alt ernating current) by means of electrodes
placed on the patient's chest.
D.2480 Cutaneous carbon dioxide (PcCO2) monitor 2 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) monitor 2 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 pressure differential across a known resistance. The device may use a set of capillaries or a metal screen forthe resistive element.
D.2600 Airway pressure monitor 2 An airway press ure 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 p urposes 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
pressure. This device includes mechanical oxygen regulators.
D.2775 Electrical peripheral nerve stimulator 2 An electrical peripheral nerve stimulator (neuromuscular bloc kade 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 transducer 1 A differential pressure transducer is a two-chambered device intended for medical purposes that is often used
during pulmonary function testing. It generates 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 convert 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 signal 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 aid 2 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 Anoropharyngeal 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 catheter 2 An anesthesia conduction catheter is a flexible tubular device use d 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 device may contain syringes, needles, and drugs.
D.5150 Anesthesia conduction needle 2 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 or analgesia 2 (a) Gas machine for anesthesia. A gas machine for anesthesia is a device used to administer to a patient,
continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device
may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.
(b)Gas machine for analgesia. A gas 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 apparatus 2 The nitric oxide administration 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 i n conjunction with a ventilator or other
breathing gas administration system.
D.5170 Laryngotracheal topical anesthesia applicator 2 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 ventilation (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 patient. The
patient blows into the device to move a column of water from one bottle to another.
D.5240 Anesthesia breathing circuit 1 Ananesthesia 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 intended
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 filter 2 A breathing circuit bacterial 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 enter a patient's
airway. The device may include a temperature controller.D.5273 Positive airway pressure delivery system 2 A positive ai rway pressure delivery system is a noninvasive ventilatory device that delivers expiratory positive
airway pressure 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 container 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 ru bber, intended for use in a breathing circuit as a
reservoir for breathing gas 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 created 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 f or 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 means 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 device 2 A high flow humidified oxygen delivery device is a device that delivers high flow oxygen with humidification
for patients who are suffering from respiratory distress and/or hypoxemia.D.5460 Therapeutic humidifier for home use 1 A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended
for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area
surrounding the patient, who breathes the vapor during normal respiration.
D.5470 Hyperbaric chamber 2 A hyperbaric chamber is a device that is intended to increase 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 direct 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 and 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 support 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 therapeutic respiratory devices.
D.5630 Nebulizer 2 A nebulizer is a device intended to spray liquids in aerosol f orm into gases that are delivered to lower respiratory
tract of the patient. This device may contain a baffle to generate homogene ous downsized aerosol. 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 liquid 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 resuscitation 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 percussor 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 c onjunction
with pulmonary function testing or for increasing minute ventilation.
D.5690 Incentive spirometer 2 An incentive spirometer is a device that indicates 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 oxygen delivered
to the patient for breathing. This generic type of device includes infant oxygen hoods.
D.5710 Electrically powered oxygen tent 2 An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically
powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases.
This generic type device includes the pediatric aerosol tent.
D.5720 Bronchial tube 2 A bronchial tube is a device used to differentially intubate 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 tube 2 A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient
for anesthesia 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 device 1 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 patient'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 cuff 2 A tracheostomy tube and tube cuff is a device 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 establish 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 accessories 1 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 accessories 2 A continuo us 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 gen eric 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 accessories such as masks of noncontinuous ventilator.
D.5915 Manual emergency ventilator 2 A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency
respiratory support by means of a face mask or a tube inserted into a patient's airway.
D.5925 Powered emergency ventilator 2 A powered emer gency 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 ventilator 2 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 attachment 2 An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that
allows spontaneous 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 pressure 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 of the patient.
D.5995 Tee drain (water trap) 1 A tee drain (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 catheter 1 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 Amedical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves
to supply gases 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, s uperficial femoral
artery stents ;(2) Class 3 devices intended to be placed other than peripheral arteries. For example, c oronary
stents, and carotid stents.
E.0002 Cardiovascular excimer laser system 3 Cardiovascular excimer laser system is intended for the photoablation or debulking of vascular lesion material
(blockages, total 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 system 2 A heart preservation/transport system is a device designed to maintain donated heart in an almost physiological
state until the heart 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 acutemyocardial 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 restrict the lesion with a high pressure balloon. It is indicated for the treatment of coronary stenosis
to improve myocardial perfusion and 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. End ovascular graft systems for aortic aneurysm
treatment and arteriovenous (A V) dialysis access circuit stenosis treatment are included in this classification.
E.0008 Percutaneous cardiac ablation system 2,3 A percutaneous cardiac ablation system is intended for cardiac ablation surgery. This system contains
percutaneous cardiac ablation catheter, RF ablation generator, cryoablation system, cooling catheter and cooling
pump. Catheter remote control system is not included in this classification. Classification : (1) Class 2: RF
ablation generator, cryoablation system, cooling catheter and cooling pump. (2) Class 3: percutaneous cardiac
ablation catheter.
E.1025 Arrhythmia detector and alarm 3 The arrhythmia detector 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 si gnal 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 Ablood pressure 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 s leeve (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 any combination of the three pressures can be derived through the use of trans ducers placed
on the surface of the body.
E.1140 Venous blood pressure manometer 2 A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the
central or peripheral venous pressure.
E.1200 Diagnostic intravascular catheter 2 An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and tointroduce substances 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 that 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 catheter system that has (a) blood f ilter(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 embolic material (thrombus/debris) from the transcatheter intracardiac proc edure
from traveling towards the cerebral circulation.
E.1255 Balloon aortic valvuloplasty catheter 2 A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended
to treat stenosis in the aortic valve when the balloon is expanded.
E.1270 Intracavitary phonocatheter system 2 An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the
associated device 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 whose movements are directed b y
a steering control unit.
E.1290 Steerable catheter control system 2 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 orsemirigid structure which can be connected to a tube or connector.
E.1310 Vessel dilator for percutaneous catheterization 2 A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the
opening in the 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 the 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 materials, 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 vein 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 computer 2 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 devices; 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 syringe 2 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 thermodi lution device to
determine cardiac output.
E.1670 Syringe actuator for an injector 2 A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic
or indicator 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 samples for 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 Athermodilution 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 conditioner 2 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 ex citation energy for the transducer
and to amplify or condition the signal emitted by the transducer.
E.2100 Cardiovascular blood flowmeter 2 A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer
and processes and displays the blood flow signal.
E.2120 Extravascular blood flow probe 2 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 signal produced by an electrocardiograph, vectorcard iograph, 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 signal 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 transducer.E.2320 Ballistocardiograph 2 A ballistocardiograph is a devi ce, including a supporting 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 of 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 adaptor 2 An electrocardiograph lead switching adaptor is a passi ve switching device to which electrocardiograph limb
and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to
the output terminals in order to create standard lead combinations such as leads I, II, and III.
E.2360 Electrocardiograph electrode 2 An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit
the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
E.2390 Phonocardiograph 1 A phonocardiograph is a device used 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 th e heart
sounds.
E.2400 Vectrocardiograph 2 A vectorcardiograph is a device used 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 display 2 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 reflected 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 amount 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
measuring electrical impedance changes in a region of the body.
E.2770 Impedance plethysmograph 2 An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electricalimpedance changes in a region of the body such as the arms and legs.
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 recorder 2 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 transducer 2 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 transducer 2 An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the
mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure
monitor that produces an analog 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 pressure from the transducer.
E.2860 Heart sound transducer 2 A heart sound transducer is an external 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 transducer 2 A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the
bloodstream, its mechanical or electrical properties change in relation to changes in bloo d pressure. These
changes are transmitted to accessory 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
conjunction 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 sign al corresponding to sounds produced
in a partially 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 c onnector) is an electrical conductor used to transmit signals
from, 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 physiological
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 inhibiting 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 from 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 filter 2 A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava 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 vessels, excluding coronary or cerebral vasculature, and to pr ovide 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 collagen, or a synthetic coating, such as silicone. The graft structure
itself is not made of materials of animal origin, including human umbilical cords.
E.3460 Endovascular suturing system 2 An endovascular suturing system is a medical device intended to provide fixation and sealing between an
endovascular graft and 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, polyethylene 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 system 2,3 (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 inflation 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) device 3 A ventricular bypass (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 generator 3 An external 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, which is used outside the body, is used as a
temporary substitute for the heart's intrinsic pacing sys tem 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 generator 3 An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that
produce a periodic electrica l pulse to stimulate the heart. This device is used as a substitute for the heart'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 is 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 function analyzer 2 A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any
or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
E.3650 Pacemaker polymeric mesh bag 1 A pacemaker polymeric mesh bag is an implanted device used 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 consis ting
of flexible insulated electrical conductors with one end connected to an external 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 transmit 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 wi th one end connected to an implantable 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 transmit 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 inhibited 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 material 3 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 tester 2 A pacemaker ele ctrode function tester is a device which is connected to an implanted pacemaker lead 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, used 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 treatment of valvular insufficiency.
E.3850 Carotid sinus nerve stimulator 3 A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulatin g
Hering's nerve at the carotid sinus.
E.3925 Replacement heart valve 3 A replacement heart 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 device used to measure the size of the natural valve opening to determine the
size of the appropriate replacement heart valve.
E.4075 Endomyocardial biopsy device 2 Anendomyocardial biopsy device is a device used in a catheterization procedure to remove samples 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 patients with acute respi ratory 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 lim ited 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 equipment 1,2 Cardiopulmonary bypass accessory equipment is a device 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 detector 2 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 cardiopulmonary surgery to
cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an
oxygenator. The device includes 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 mac hine. 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 defoamer 2 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 exchanger 2 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 cardiopulmonary 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 cardiopul monary 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 obstruct circula tion by blocking a vessel) out of the blood. This device is intended
for use in the cardiotomy suction line.
E.4280 Cardiopulmonary prebypass filter 2 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 unit 2 A cardiopulmonary bypass gas control unit is a device used to control a nd measure the flow of gas into the
oxygenator. The device 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 pulsatile blo od 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 in the blood reservoir and to sound an alarm when the level falls below a predetermined value.
E.4350 Cardiopulmonary bypass oxygenator 2 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 control 2 A cardiopulmonary bypass 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 pump tubing 2 A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is
cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.
E.4400 Cardiopulmonary bypass blood reservoir 2 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, and 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 instruments 1 Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular
surgery. These 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
arteriosclerotic 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 apparatus 2 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 special 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 manually powered
and is used to compress the chest periodically i n 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/or 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 opt imal 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 provides 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,
compression depth, ventilation, recoil, instruc tion for one or multiple rescuers, etc.). These devices may alsoperform 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 device 2,3 (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 in cludes low energy defibrillators with a maximum electrical output of less than 360
joules of energy that are used in pediatric defibrillation or in cardiac surgery. 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 2.
(b)High-energy DC-defibrillator (1)Identification: A high-energy DC-def ibrillator 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 terminate other cardiac arrhythmias. 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 system 3 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 elect rode,
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 defibrillator 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 cardiac
pacemaker(noninvasive)2 An external transcutaneous cardiac pacemaker (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.E.5700 Steerable cardiac ablation catheter remote
control system2 Asteerable cardiac ablation catheter remote control system is a device that is external to the body and interacts
with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction,
rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias
in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation
catheter without withdrawal 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 temperature controller for the device. The system is used to regulate patient temperature.
E.5910 Esophageal thermal regulation device 2 An esophageal the rmal 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 suctioning. The device is used to regulate patient temperature.
E.5925 Automatic rotating tourniquet 2 An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily
reduces the total 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 software 2 Orthodontic Planning Software is a software that is to be used fo r 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 frequency 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 device 2 A laser fluorescence caries detection device 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 fluorescencemeasurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring
increased laser induced fluorescence.
F.1800 Extraoral source x-ray system 2 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 system 2 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 device 1 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 device 1 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 the dental x-ray field by limiting the size of the primary x-ray beam.
F.1850 Lead-lined position indicator 1 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, probe tips, cables,
and accessories. This device is intended to be used in vivo, to manually measure per iodontal pocket probing
depths, detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal
pockets, as an adjunct 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 s onography device for interpretation and diagnosis is an electrically powered
device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint
disorders and associated orofacial pain. The device detects, records, dis plays, and stores sounds made by the
temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful
output, either directly 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 o f the mandible with respect to the location and position of the maxilla, while at
rest and during jaw movement.(2)Classification: Class 1.(b)Jaw tracking device for interpretation of mandibular
jaw positions for the diagnosis (1)Identification. A jaw track ing device for interpretation of mandibular jaw
positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofacial
pain is a nonpowered or electrically powered device that measures and records anatomical dista nces and angles
to determine the relative position of the mandible in three- dimensional space, with respect to the location and
position of the maxilla, while at rest and during jaw movement. The device records, displays, and stores
information about jaw p osition. 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 composed 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 alloy 2 Dental amalgam 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 predosed capsule form, for the direct filling of carious lesions or structural defects
in teeth. This device also i ncludes 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 alloypellets.
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 containe r 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 austenitic 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 durin g 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 containing 75 percent or
greater gold and metals of the platinum group intended for use in prosthe tic dentistry in conjunction with
removable partial dentures. Various forms of 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 correct 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 mouth, 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 liner 2 A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity
before insertion of restorative material, e.g., amalgam etc., to protect the pulp of a tooth.
F.3260 Cavity varnish 2 Cavity va rnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before
insertion of restorative 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 temporarytooth filling, to affix dental 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 w ire clasp is a prefabricated device made of austenitic alloys or alloys
containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental
appliance, such as a partial denture, to help stabilize the appliance i n the patient's mouth by fastening the
appliance to an adjacent tooth.
F.3300 Hydrophilic resin coating for dentures 2 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 fillings 2 A coating material for resin fillings is a device intended to be applied to the surface of a r estorative resin dental
filling to attain a smooth, glaze-like finish on the surface of the filling.
F.3330 Preformed crown 1 A preformed crown is a prefabricated device 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 normally 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 prefab ricated 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 permanent 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 alloys 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 achieve 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 sodi um 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 denture before the denture is inserted into
patient's mouth to improve denture retention and c omfort.(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 1 An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containingcarboxymethyl-cellulose sodium denture
adhesiveethylene oxide homopolymer and/or carboxymethylcellulose 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 A carboxymethylcellulose 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 and comfort.
F.3480 Polyacrylamide polymer (modified cationic)
denture adhesive3 A polyacrylamide polymer (modified cationic) denture 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 denture 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 i s 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 retention and comfort.
F.3500 Polyvinylmethylether maleic anhydride (PVM-
MA), acid copolymer, and
carboxymethylcellulose sodium (NACMC)
denture adhesive)3 Polyvinylmethylether maleic anhydride (PVM- MA), acid copolymer, and carboxymethylcellulose sodium
(NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer,
and carboxymethylcellulose 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.3520 OTC dental appliance cleanser 1 An OTC dental appliance cleanser is a device that consists of material in the form of a powder, tablet, or paste
that is intended to remove debris from removable prosthetic dental appliances, such as bridges , dentures, braces,
and retainers. The dental appliance 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 de nture 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 consisting 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 toreplace 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, that 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 tooth 1 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 tooth 2 A preformed plastic denture tooth is a prefabricated device, composed of m aterials such as methyl methacrylate,
that is intended for use as a tooth in a denture.
F.3600 Partially fabricated denture kit 2 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 the 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 preformed teeth are chemically bonded to the base.
F.3630 Endosseous dental implant abutment 2 An endosseous dental implant abutment i s 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 surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices,
such as artificial teeth, in order to restore a patient's chewing function.
F.3645 Subperiosteal implant material 2 Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to
construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the
periosteum (connective tiss ue 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 t o 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 for study and for production of restorative prosthetic devices, such as gold inlays
and dentures.
F.3661 Optical Impression Systems for CAD/CAM 1 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 material 1 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 prefor med 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 t o form a custom tray. This tray is then filled
with impression material and inserted into the patient's mouth to make an impression, from which 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 carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or
lower jaw area that con tains 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 are 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 metals of the platinum group intended to be placed permanently in a tooth to provide retention and
stabilization for a restoration, such as a crown, or to join two or more teeth together.
F.3750 Bracket adhesive resin and tooth conditioner 2 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 resin 2 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 available for over-the-counter (OTC) use.
F.3765 Pit and fissure sealant and conditioner 2 Apit and fissure sealant and conditioner 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 resin 2 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 platinum 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
ingredient 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 coagulated sap of certain tr opical 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 insert 1 A posterior ar tificial tooth with a metal insert 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 surrounding te eth 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 tooth 1 A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable
dental appliance, 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 too th is a prefabricated device made 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 such 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 joint prosthesis 3 A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to
replace the m andibular 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 augmenta glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
F.3960 Mandibular condyle prosthesis 3 A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to replace the
mandibular condyle 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 natural articulating surface of the mandibular condyle and glenoid fossa.
F.3980 Endosseous dental implant accessories 1 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 endosseous 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 endosseous 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 accessories 2 A bone cutting instrument 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 accessories 1 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 device 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 injector 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 of 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 oralsurgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental
amalgam carver, surgical bone chisel , operative amalgam and foil condenser, endodontic curette, operative
curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative
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 instrument, operative margin finishing periodontic knife, periodontic marker,
operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch,
endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp
canal filling material spreader, surgical o steotome chisel, endodontic broach, dental wax carver, endodontic pulp
canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument,
dental instrument handle, surgical tissue scissors, mouth mirror, ort hodontic band driver, orthodontic band
pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking
instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retai ner, dental
retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression
material syringe.
F.4600 Intraoral ligature and wire lock 2 An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral
cavity. The bone 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 recon struction 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 during 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 deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
F.4880 Intraosseous fixation screw or wire 2 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 and accessories 2 A dental electrosurgical unit and accessories is an AC- powered device consisting of a controlled power source
and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control
bleeding during surgical 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 accessories 1 An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is
affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic
band, orthodontic band material, o rthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp,
preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic
tube, and orthodontic wire.
F.5470 Orthodontic plastic bracket and aligner 2 (a)An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a
tooth from a flexible 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 t he patient's
dental digital scan file.
F.5500 Extraoral orthodontic headgear 2 An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure
on the teeth from outside the mouth. The headgear has a strap in tended 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 impression 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 patient bites down on the device for several hours a day to stabilize t he position of the
teeth.
F.5560 Electrical salivary stimulatory system 2 An electrical salivary stimulatory system is an intraoral device that is intended to electrically stimulate a relativeincrease 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 obstr uctive 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 retaining devices, and mandibular repositioning devices.
F.6010 Abrasive device and accessories 1 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 a s 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 abrasive disk, guard for an abrasive disk, abrasive point, polishing agent
strip, and polishing wheel.
F.6030 Oral cavity abrasive polishing agent 1 An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material,
such as silica 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 polymerization 2 An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize
(set) resinous 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 paper 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 during 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 l atex with a hole in the 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 tooth by inserting a tooth through a hole in the center. The device include s the rubber dam,
rubber 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 invisible material, such as dental plaque, present in or on teeth.
F.6475 Heat source for bleaching teeth 1 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 hollow tube is filled with impression material. One end of the tube is sealed with a softened material,
such as wax, the remaining end is slipped over the tooth to make the impression.
F.6640 Dental operative unit and accessories 1 A dental operative unit and accessories is an AC- powered device that is intended to supply power to and serve
as a ba se for other dental devices, 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 use 2 Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances
intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings,
and veneers. The device is used in prosthetic 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 that 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 sterilizer 3 An endodontic dry heat s terilizer is a device intended 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 anesthetic 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 needl e 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 in tended 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 ho ld impression material, such 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 make 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 using 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
andsignals 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 sensitivity 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 measure and graph the mobility characteristics of the tym panic 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 fluid in the middle ear cavity. The device is als o 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 testing 1 An earphone 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 audiometric
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 empl oys a pair of electrodes that are placed in contact withthe 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 laryn geal diagnosis, aid
behavioral 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 olfacto ry loss is present. The device includes 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 stimulator 1 An air or water caloric stimulator is a device t hat delivers a stream of air or water 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 stimulation of the semicircular canals produce involu ntary eye movements that are
measured and recorded by a nystagmograph.
G.1820 Surgical nerve stimulator/locator 2 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 system 2 A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess
the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing
aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity
volume, a sound 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 aid 2 A tympanic membrane contact hearing aid is a device that 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 trainer 2 A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicatingsimultaneously with one or more listeners having hearing impairment. The device is used with an associated
transmitter microphone. I t 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 wearable 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 m ask 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 of the tympanic membrane. The device permits an ample air- filled 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 prosthesis 2 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 conduction 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 f ibers composite, absorbable gelatin material, porous
polyethylene, or from a combination of these materials.
G.3495 Total ossicular replacement prosthesis 2 A total ossicular replacement prosthesis is a device intended to be implanted for the total funct ional
reconstruction of the ossicular chain and 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 com posite, 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 2 Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use asmaterial a space-occupying substance in the reconstructive surgery of the head and ne ck. The device is used, for example,
in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by
the surgeon to conform to the patient's needs. This generic type of device is made of material such as polya mide
mesh or foil and porous polyethylene.
G.3695 Mandibular implant facial prosthesis 2 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 patient. 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 that 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
symptoms of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of
the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of
polytetrafluoroethylene or silicone elastomer.
G.3850 Endolymphatic shunt tube with valve 2 An endolymphatic shunt tube with valve is a device that consists of a pressure- limiting valve associated with 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 intended 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 attaches 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 temporary relief from transient causes of breathing difficulties
resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasalairflow. The device decreases 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 action 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 is 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 membrane 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 interna l 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 surgery, 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 dilating the eustachian tube. This generic type of device includes eustachian catheters.
G.4180 Eustachian tube balloon dilation system 2 A Eustachian tube balloon dilation system is a device that includes a flexible catheter attached to an inflatable
balloon. The 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 throatendoscope. Endosco pic devices which utilize fiberoptic light sources and carriers include 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 devices 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 includ es 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; mouth gag; oral screw; salpingeal
curette; tonsillectome; tonsil guillotine; 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; n asal scissors;
nasal snare; sinus irrigator; sinus trephine; ear curette; 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 clam p; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and
throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.
G.4490 Argon laser for otology, rhinology, and
laryngology2 The argon laser device for use in otology, rhinology, and laryngology is an electro- optical device which produces
coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the
device is used for the purpose of coagulating a nd 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 laser 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 which attach to the bronchoscop e and is intended to examine or treat the larynx and
tracheobronchial tree. 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 t ype of device includes the
rigid ventilating bronchoscope, rigid nonventilating 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 bronchoscope 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 malfunctionsymptoms, esophageal or mediastinal disease, or to remove foreign bodies from t he esophagus. When inserted,
the device extends from the area of the hypopharynx 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 excludes the fiberoptic light
source and carrier.
G.4720 Mediastinoscope and accessories 2 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 is inserted transthoracicly and is used in diagnosis 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 cure tte, but excludes the fiberoptic light source and
carrier.
G.4750 Laryngostroboscope 1 A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The
device operates 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 (flexible or rigid) and
accessories2 Anasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of
accessory devices which 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 made of materials such as stainless steel and flexible plastic. This generic type of device includes the
antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, post rhinoscope, 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 and 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 minimize 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.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 otologic 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, etc.) 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 exami nation while providing specialized features for examination and treatment. The unit
consists 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 used 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 dev ice
includes a plastic instrument with serrated ends that is inserted into the airway in a blind 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 conn ected 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 speech 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 system 2 Ahemodialysis dialyzer reprocessing system is intended to clean and disinfection of reusable dialyzers. 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 instrument 1,2 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. Th is section does not apply to biopsy instruments that have been used in other
medical specialty areas 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 perform 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 System 2 A single- use ingestible capsule 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 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 which 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 inse rted into body spaces and may include an optical system for conveying an image to the
user's eye and their 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 of device include cleaning
accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular
attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnost ic
cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes,
fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes,
resectoscopes, nephroscopes, sigmoidoscopes, u reteroscopes, urethroscopes, endomagnetic retrievers, cytologybrushes for endoscopes, biopsy tissue forceps used with endoscopes, and lubricating jelly for transurethral
surgical instruments. This section does not apply to endoscopes that have been used i n other medical specialty
areas or covered by endoscopes of relevant classification categories. Classification: (1) Class 2. (2) Class 1 for
the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for
endo scope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for
panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope,
smoke removal tube, rechargeable batte ry box, pocket battery box, bite block for endoscope, and cleaning brush
for endoscope.
H.1620 Urodynamics measurement system 1 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 record the electrical activity of the muscles associated with urination. The device system
may include transducers, electronic signal co nditioning and display equipment, a catheter withdrawal device to
enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes
for electromyography. This generic type of device includes the cystometric g as (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 system 2 A gastrointestinal motility monitoring 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 include signal conditioning, amplifying, 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, amplifier, 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 exter nal recorder, amplifier, skin
electrodes, strip chart, cables, analytical software, and other accessories.
H.1800 Urine flow or volume measuring system 1 A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of
urine from a patient, either 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 electrica l 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 system 2 A prostate lesion documentation system is a device intended for use in producing an image of the prostate as anaid in documenting prostate abnormalities previously identified during a digital rectal examination. The device
uses press ure sensors and image reconstruction 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 influencing 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 reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual 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 catheter 2 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 use d during the loop colostomy procedure. 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 through the surgical opening.
H.4300 Endoscopic electrosurgical unit and accessories 2 An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures
through an endoscope. This generic type of device includes the electrosurgical generator, patient pl ate, electric
biopsy forceps, electrode, flexible 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 instruments, the electric cord for transurethral surgical
instruments, and the transurethral desiccator.
H.4370 Gastroenterology -urology evacuator 1,2 A gastroenterology-urology evacuator is a device used to remove deb ris 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 tissue by means of a ligatureor 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 voltage source 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 retractor 1 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 consists 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 instruments 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 repair of a ruptured urethra. The device may includ e 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 protru sions 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 system 1 A water jet renal stone dislodger system is a device used to dislodge stones from re nal calyces (recesses of the
pelvis of the kidney) 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 expandable 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 the ureter. This generic type of device inc ludes 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 is 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 accessories 1,2 A urological table and accessories is a device that consists of a table, stirrups, and b elts used to support a patient
in a suitable position 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 manually powered table and accessories, and for stirrups for electrically
powered table.
H.5010 Biliary catheter and accessories 2 A biliary catheter and accessories is a tubular flexible device used for tempor ary 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 include a bile collecting bag that is attached to the biliary catheter by a connect or 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
removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.
H.5020 External penile rigidity devices 2 External penile rigidity devices are devices intended to cre ate or maintain sufficient penile rigidity for sexual
intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which
are mechanical, powered, or pneumatic devices.
H.5025 Vibrator for climax control of premature
ejaculation2 A vibrator for climax control of premature 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 catheter 1 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 period ically by the patient for
routine care to empty the ileal pouch. This generic type of device includes the rectal catheter for continent
ileostomy.
H.5090 Suprapubic urological catheter and accessories 1,2 A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the
abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids toand from the urinary tract. This generic type of device includes the suprapubic cat heter 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 accessories 1,2 A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to
pass fluids to or from the urinary tract. This generic type of device incl udes radiopaque urological catheters,
ureteral catheters, urethral 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 accessories including ureteral catheter stylets, ureteral catheter
adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-
urological irrigation tray (for urological use). Classification: (1) Class 2 ;(2)Class 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 drainage 2 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 voidi ng is
desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot
empty their bladder due to impaired detrusor contractility.
H.5160 Urological clamp for males 1 A urological clamp for males is a device us ed to close the urethra of a male to control urinary incontinence 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 promote evacuation of the contents of the lower colon. The device consists of a container for fluid
connected to the nozzle either directly 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 during the administration of the colonic irrigation. The device consists of a container for
fluid connected to the nozzle via tub ing and includes a system which enables the pressure, temperature, or flow
of water through the nozzle to be controlled. The device may include a console- type toilet and necessary fittings
to allow the device to be connected to water and sewer pipes. The d evice 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 devicesintended for other uses, including colon cleansing routinely for general well being.
H.5250 Urine collector and accessories 1,2 (a)A urine collector and accessories is a device intended to collect urine. The device and accessories consist of
tubing, a suitable 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 indw elling catheter, which includes the urinary drainage
collection kit and the closed urine drainage system and drainage bag. (2) A urine collector and accessories
not intended to be connected to an indwelling catheter, which includes the corrugated rubber sh eath,
pediatric 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 device 3 An implanted electrical urinary device is a device intended for treatment of urinary inconti nence 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 incontinence by
the application of continuous or intermittent pressure to occlude the urethra. The totally implan ted 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 the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff
around the urethra. T he fluid is pumped as needed from the container to inflate the pad or cuff to pass on the
urethra.
H.5310 Nonimplanted, peripheral electrical continence
device2 A nonimplanted, peripheral electrical continence device is a device that consists of an elect rode that is connected
by an electrical cable to a battery- powered pulse source. The electrode is placed onto or inserted into the body
at a peripheral 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 continence 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 r emoved 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 ga strointestinal bougies and the
esophageal dilator (metal olive).
H.5450 Rectal dilator 1 A rectal dilator is a device designed to dilate the anal sphincter 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 dilate 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 material 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 filiform 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 delivery device is inserted transurethrally 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 the treatment of symptoms due to urinary outflow obstruction
secondary to benign prostatic hyperplasia in men.
H.5540 Blood access device and accessories 1,2 (a)A blood access device and accessories is a device intended to provide access to a patient's blood for
hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system fo r
the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for
hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and
accessories for both the implanted an d 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, a nd are intended to remain
in 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 which may provide additionalfunctionality to the device. (2)The nonimplanted blood access device con sists of various flexible or rigid
tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels 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)Accessories common to either type include the shunt adaptor,
cannula clamp, shunt connector, shunt stabiliz er, vessel dilator, disconnect forceps, shunt guard, crimp plier,
tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)Classification: (1) Class 2 for the implanted blood access device; (2) Class 2 for the nonimp lanted 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 rin g, 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 blood 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 conditions. The sorbent
cartridge may include absorbent, ion exchange and catalytic materials.
H.5630 Peritoneal dialysis system and accessories 2 (1)A peritoneal dialysis system and accessories is a device that is us ed 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
administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water pur ification
mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that
undesirable substances from the patient'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 temperature, volume, and delivery rate together with the
time course of each cycle of filling, dwell tim e, and draining of the peritoneal cavity or manual controls may be
used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(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, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal cathe ter.Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the
patency of the surgical fistula in the abdominal wall between treatments.(3)The disposable administration set for
peritoneal dialysis cons ists of tubing, an optional reservoir bag, and appropriate connectors. It may include a
peritoneal dialysate filter to trap and remove contaminating particles.(4)The source of dialysate may be sterile
prepackaged dialysate (for semiautomatic peritoneal dia lysate delivery systems or "cycler systems") or dialysate
prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery
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 hemodialysis 2 A water purification system for hemodialysis 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 accessories 1,2 (a)A hemodialysis 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 an extracor poreal blood system, a
conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the
tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then
returns through furt her 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 the 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 compartment 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 dialyzer 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 hemodialyzers with the disposable inserts (Kiil type) or dialyzers of high
permeability.(3) The dialysate delivery system consists of m echanisms 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 forhemo dialysis (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 d ialysis system and accessories, or the controlled
dialysate delivery system of the high permeability hemodialysis system (H.5860 ).(4) Remote accessories to
the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis c hair
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 accessories that are directly related to the
extracorporeal blood system, and the dialysate delivery system ;(2) Class 1 for ex tracorporeal blood system
and dialysate delivery system that remote hemodialysis system and other accessories, such as non- powered
dialysis 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 artificial 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 system 2 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, hemofiltrati on, 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 toxi ns or excess fluid
from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (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 and/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 through the system, and the rate at which
fluid is removed from the patient. The high permeability hemodialysis system consists of the 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 imbalance.(2) The hemodialysis delivery machine is similar to the
extracorporeal blood system and dialysate delivery system of the h emodialysis system and accessories, with the
addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid
balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, u rea, etc.).(3)
The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various
treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, blood recirculation monitors, etc.).
H.5870 Sorbent hemoperfusion system 3 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 rang e of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are
usually activated- carbon or resins which may be coated or immobilized to prevent fine particles entering the
patient's blood. The generic type of device may include lines and 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 cell 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 accessories 1 An ostomy pouch and accessories is a device that consists 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 followingan ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or
the ureter on the surface of the body). This generic typ e 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, osto my 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 to allow normal 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 peritoneal 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 accessories 1,2 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 alimentary tract. This device may
incorporate an integral inflatable balloon for rete ntion or hemostasis. This generic type of device includes the
hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set,
gastrointestinal string and tubes to locate internal bleeding, double lum en 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 ga strological
use).Classification: (1)Class 2 ;(2)Class 1 for the dissolvable nasogastric feed tube guide for the nasogastric tube.
H.5990 Extracorporeal shock wave lithotripter 2 An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to
noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a
shock wave generator, high voltage 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 spark discharge (spark gap), electromagnetically
repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with 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 fragmentedby 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 de vice 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 action. 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 be implanted in facial or other body
surface where weakness exists.
I.0003 Ultrasonic surgical instrument 2 An ultrasonic surgical instrument is a surgical device for soft tissue ablation. This device contains ultrasound
generator and 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 intended 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 Hyaluroni c acid implants are hyaluronic acid substances used to modify or filled into surface defects on the face
or other body positions.
I.0008 Transcutaneous skin stimulator 2 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 tissue. 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
tissues 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 i nto a body cavity to aid observation. It is either nonilluminated
or illuminated and may have various accessories.
I.3250 External facial fracture fixation appliance 1 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 whe re
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 pol ytetrafluoroethylene 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 prosthesis 3 A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as
polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline
before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.
I.3540 Silicone gel-filled breast prosthesis 3 (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 time 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 polydiphenylsiloxane. The inner shel l 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 be 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
polydimethylsiloxane and polydiphenyl siloxane, 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 structure compartmentalizing t he 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 expandable 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 unbranched or contain one or two branches. The metal tracheal prosthesis may
be uncovered or covered with a polymeric material. This device may also include a device delivery system.
I.3800 External aesthetic restoration prosthesis 1 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 splint 1 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 accessories 1 A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies.
The kit contains surgical instruments and materials used to make maxillofacial impres sions 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, including laparoscopic incisions, and simple 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-topical use, inc luding 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 edges 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 closur e device component maintains temporary skin edge alignment along the length ofwound during application of the liquid adhesive..
I.4014 Nonresorbable gauze/sponge for external use 1,2 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 2nd 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 consists 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 d evices 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 dressing 1,2 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 of 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 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.4022 Hydrogel wound dressing and burn dressing 1,2 A hydrogel wound dressing is a sterile or non-s terile 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 nonresorbable matrix made of hydrophilic polymers or other mate rial 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
antimic robial 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 product 1 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 pro tect both the surgical patient and the operating room personnel from transfer of microorganisms, body
fluids, and particulate material. Examples include surgical caps, hood s, 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 labell ed/claimed to have the 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.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 accessories 1 A surgical camera and accessories is a device intended to be used to record operative procedures.
I.4165 Wound autofluorescence imaging device 2 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 accessories 1 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to
introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, 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 intended 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 system 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 accessories 2 (1)Cryosurgical uni t with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquidnitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by
applying extreme cold.(2)Cryosurgical unit with a ni trous oxide cooled 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 applications, by applying extreme cold.(3)Cryosu rgical unit
with 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 accessories is a device
intended to destroy tis sue during surgical 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 gy necological conditions 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 accessories 1,2 (a) A surgic al drape and drape 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 wou nd 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 device 2 An irrigating wound retractor device is a device intend ed 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 surgical 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 bleeding by use of high-frequency electrical current.
I.4410 Low energy ultrasound wound cleaner 2 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 maintenance debridement of wounds. Low levels of ultrasound
energy may be carried to the wound by the 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 foruse as a bandage over the eye for protection or absorption of secretions.
I.4450 Nonabsorbable gauze for internal use 1 Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the
body or a surg ical 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.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 surgeon'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 barr ier property (water leak) and tensile strength
should comply with ISO 10282, ASTM D 3577, EN 455 or equivalent standards. A non- powdered (powder free)
surgeon's glove should comply with EN ISO 21171, ASTM D 6124 or equivalent standards. The 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 corn 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 putting on a surgeon's glove. The device is absorbable through biological
degradation.
I.4490 Absorbable hemostatic agent and dressing 3 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- lactide, 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 without a standard needle attached.
I.4494 Absorbable poly(hydroxybutyrate) surgical
suture produced by recombinant DNA
technology2 An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated
from prokaryotic 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.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 thr ough 10, or a substantially equivalent stainless steel suture, intended for use in
abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.
I.4520 Polytetrafluoroethylene injectable 3 Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene
intended to be 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 or the patient.
I.4590 Focused ultrasound stimulator system 2 A Focused Ultrasound Stimulator 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 membrane disruption intended for noninvasive use.
I.4630 Ultraviolet lamp for dermatologic disorders 2 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 dermatologic 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 marker 2 An Aorto- saphenous vein ostia marker is used as a landmark to identify the 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 surgical
incision sites or mark anatomical sites for accurate blood pressure measurement.
I.4670 Internal tissue marker 2 An internal tis sue marker is a use device that is intended for use prior to or during general surgical procedures
to demarcate selected 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
indicated for wound management via application of negative pressure to the wound for removal of fluids,
including wound exudate, irrigation f luids, and infectious materials. It is further indicated for management of
wounds, burns, flaps, and grafts. Classification. Class 2.
I.4685 Extracorporeal shock wave device 3 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 accessories 1 A surgical microscope and accessories is an AC- powered device intended for use during surgery to provide a
magnified view of 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 intended to be used to
dissolve surface skin oil or adhesive tape.
I.4750 Implantable staple 2 An implantable staple is a staple-like devi ce 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 use 1 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, 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.
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 system 2 A magnetic surgical instrument system is a device used in laparoscopic surgical procedures consisting of several
components, such as surgical instruments, and a magnetic controller. The ma gnetic 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 are AC-powered, battery-powered, or air- powered devices intended
for use during surgical procedures to provide power to operate various accessories or attachments to cut hardtissue 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.
I.4830 Absorbable surgical gut suture 2 An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared
from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of shee p (ovine)
intestine, and is intended for use in soft tissue approximation.
I.4840 Absorbable polydioxanone surgical suture 2 An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared
from polyester polymer poly (p- dioxanone) and is intended for use in soft tissue approximation, including
pediatric cardiovascular tissue where growth is expected to occur, 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 aid 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 accessories 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 terephthalat e) surgical suture is a multifilament, nonabsorbable, sterile, flexible
thread prepared from fibers of high molecular weight, long- chain, linear polyesters having recurrent aromatic
rings as an integral component and is indicated for use in soft tissue app roximation. 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 suture 2 Nonabsorbable polypropylene surgical sutu re is a monofilament, nonabsorbable, sterile, flexible thread prepared
from long- chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue
approximation. It may be undyed or dyed with an FDA approved color additive; and the s uture may be
provided with or without a standard needle attached.
I.5020 Nonabsorbable polyamide surgical suture 2 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 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.5030 Natural nonabsorbable silk surgical suture 2 Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of
an organic 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 indica ted for use in soft tissue
approximation. Natural nonabsorbable silk surgical 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
polytetrafluoroethylene surgical suture2 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. It 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 contouring. 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 bo ttle and the safety trap), collection bottle, cannula, and connecting tube. 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 horsepow er, a variable vacuum range from 0 to 29.9 inches of
mercury, vacuum control 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 has been filtered to remove particulate matter and m icroorganisms to provide an area free of
contaminants to reduce the possibility 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 to 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 device 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 extremities 3 A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and applyhumidified 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 tightened 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 irrigation 2 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 strip 1 A liquid crystal forehead temperature 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 co lor changes of heat
sensitive liquid crystals corresponding 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 Anelectronic 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 fluid 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 elect rical signal. The device
includes signal amplification, 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 inserted int o 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 imagescapturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.
J.2800 Sterilization process indicator 2 (a)Biological sterilization process indicator -- (1)Identification: A biological sterilization process indicator is a
device intended for use by a health care provi der to accompany products being sterilized through a sterilization
procedure and to monitor 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 enclose d in a protective package.
Subsequent growth or failure of the microorganisms to grow under 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 health care provider to
accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of
the sterilization process. The adequac y of the sterilization conditions as measured by these parameters is
indicated by a visible change in the device. (2)Classification: Class 2.
J.2900 Clinical color change thermometer 1 A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary
(armpit) body temperature. The device records 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 thermometer 2 A clinical electronic thermometer 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 u nit. The transducer may
be in a detachable probe with or without a disposable cover.
J.2920 Clinical mercury thermometer 1 A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature
using the thermal expansion of mercury.
J.5025 I.V . container 2 An I.V . container is a container made of plastic or glass used to hold a fluid mixture to be administered to a
patient through an intravascular administration set.
J.5045 Medical recirculating air cleaner 2 Amedical recirculating air cleaner is a device used to remove particles from the air for medical 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 support 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: other devices.
J.5090 Liquid bandage 1,2 A liquid ban dage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover
an opening in the skin or as a dressing for burns. The device is also used as a topical skin
protectant.Classification: (1)Class 2 devices that are intend ed for patients with class 3 burning wound, freesewing(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.
J.5100 AC-powered adjustable hospital bed 1 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 heigh t and surface
contour of the bed. The device includes movable and latchable side rails.
J.5110 Hydraulic adjustable hospital bed 1 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 bed 1 A manual adjustable hospital bed is a device intended for medical purpose s 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 warmer 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 output control mechanism, and an alarm sy stem (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, fixed end rails, movable and lat chable side rail components, and possibly an accompanying mattress. The
contour of the crib surface may be adjustable.
J.5150 Nonpowered flotation therapy mattress 1 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).
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 secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic
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 serve 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 inserted into the patient's vascular system for short term use (less than 30 days) 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 device 1 An intravascular catheter securement 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 bandage 1,2 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 device is used to cover and pr otect 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(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.
J.5270 Neonatal eye pad 1 A neonatal eye pad is an opaque device used t o 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 surface. 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 environment for medical care. The device may include an AC- powered heater, a fan to circulate the
warmed air, a container f or 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 insulate d 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 . bag 1 A pressure infusor for an I.V . bag is a device consisting of an inflatable cuff which is placed around an I.V . bag.
When 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 injector 2 A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider togive 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 set 2 An intravascular 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 chamber, an infusion line filter, an I.V . set stopcock, fluid delivery tubing, connectors
between parts of the set, a side tube with a cap 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 chamber 2 A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the
entry of harmful airborne material. This device protects a patient who is undergoing treatment f or 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 clean 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 from a bed to a bath. The device includes
straps and slings to support the patient.
J.5510 Non-AC-powered patient lift 1 A non-AC- powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile,
used to lift and transport a pati ent 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 mattress 1 An alternating pressure air flotation 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, and automatic changes in the distrib ution of body pressure. The device is used to
prevent and treat decubitus ulcers (bed sores).
J.5560 Temperature regulated water mattress 1 A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of
suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical
heating and water circulating components, and an optional cooling component. The temperature control may be
manual or automatic.
J.5570 Hypodermic single lumen needle 2 A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of thebody below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the
other 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 practice of acupuncture. The device consists
of a solid, stainless steel 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 include 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 kit 3 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 1,2 (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 for general medical purposes -- (1)Identification: A medical support stocking for
general medical purposes is a de vice 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.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 waistband and that is used to support the scrotum (the sac that contains the testicles).
J.5860 Piston syringe 2 A piston syri nge 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 connector
(hub) of a hypodermic single lumen needle. The dev ice 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 vessels 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 reservoir that connects to a long-term intravascular cathe ter. 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 outlet 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 sampling 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 devi ce intended for medical purposes that consists of an absorbent swab on
a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from a patient.
J.6100 Ethylene oxide gas aerator cabinet 2 An ethyene oxide gas aer ator 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 required to remove residual ethylene oxide (ETO) f rom 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 instruments 1 An ultrasonic cleaner for medical 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 finger 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 o f EN ISO 21171, ASTM D 6124 or
equivalent standards. The amount of residual powders on a glove should not exceed 2.0 mg.
J.6280 Medical insole 1 A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptom s
of athlete's foot infection by absorbing moisture.
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 enable 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 uniqu e electronic identification code that is read by the scanner. The identification code is used to access patient
identity and corresponding health information 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 measu red amount
of liquid medication.
J.6450 Skin pressure protectors 1 A skin pressure protector is a device intended for medical purposes that is used to 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 apparatus 1 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 generic type of device includes vacuum regulators,
vacuum collection bottles, suction catheters and tips, conn ecting flexible aspirating tubes, rigid suction tips,
specimen traps, noninvasive tubing, and suction regulators (with gauge).
J.6775 Powered patient transfer device 1 A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that
has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the
patient with minimal disturbance in a horizontal position to the stretcher.J.6785 Manual patient transfer device 1 A ma nual 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.6820 Medical disposable scissors 1 Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This
generic type of device does not include surgical scissors.
J.6850 Sterilization wrap 2 A sterilization wrap (pack, sterilizat ion wrapper, bag, or accessories, is a device intended to be used to enclose
another medical device that is to be sterilized by a health care provider. It is intended 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 provider 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 provid er to sterilize medical
products by means of pressurized steam.
J.6885 Liquid chemical sterilants/high level
disinfectants2 A liquid chemical sterilant/high level 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 spaces during use. Semicritical devices make contact during use with mucous
membranes or nonintact skin.
J.6890 General purpose disinfectants 1 A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment
surfaces. A general purpose disinfectant can be used to 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.
J.6900 Hand-carried stretcher 1 A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal
platform, on which a patient can be carried.
J.6910 Wheeled stretcher 1 A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport
patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and
patient securement straps. The 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 medical purposes that consists of a bulb or a piston syringe withan 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 purp oses to clean surgical instruments,
anesthesia equipment, hollowware, and other medical devices.
J.6992 Medical washer-disinfector 2 A medical washer- disinfector is a device that is intended 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
effectiveness of drugs or other treatments.
K.1030 Ataxiagraph 1 Anataxiagraph 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- scan, 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 electrodes 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 stimulating 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., the electroencephalogram) 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 thepurpose 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 placing 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 esthesiometer 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 device 2 A galvanic skin response measurement device is a device used to determine autonomic responses as
psychological indicators by meas uring the electrical resistance of the skin and the tissue path between two
electrodes applied to the skin.
K.1550 Nerve conduction velocity measurement device 2 A nerve conduction velocity measurement 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 and displaying the nerve conduction time.
K.1560 Skin potential measurement device 2 A skin pot ential 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 w hich 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
electroencephalogram which is referred to as the alpha wave.
K.1620 Intracranial pressure monitoring device 2 An intracranial pressure monitoring device is a device used for short- term monitoring and recording ofintracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting
hardware.
K.1630 Cranial motion measurement device 2 A cranial motion measurement device is a device th at utilizes accelerometers to measure the motion or
acceleration of the skull. These measurements are not to be used 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 impedance methods with direct electrical connections to the scalp or neck area.
K.1835 Physiological signal amplifier 2 A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from
various physiological sources (e.g., the electroencephalogram).
K.1845 Physiological signal conditioner 2 A physiological sig nal conditioner is a device such as an integrator or differentiator used to modify physiological
signals for recording and processing.
K.1855 Electroencephalogram (EEG) telemetry
system2 An electroencephalogram (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 stimulator 2 An evoked response electrical stimulator is a device us ed 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 stimulator 2 An evoked response mechanical stimulator 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 stimulator 2 An evoked response photic stimulator is a device used to generate 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 stimulator 2 An evoked response auditory stimulator is a device that produces a sound stimulus fo r use in evoked response
measurements or electroencephalogram activation.
K.1935 Near infared (NIR) brain hematoma detector 2 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 brain 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 instrument 1 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 used 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 without 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 cutting 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 handpiece (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 power source used with removable rotating surgical
cutting tools or drill bits on a patient's skull.
K.4370 Pneumatic cranial drill motor 2 A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical
cutting tools or drill bits on a patient's skull.
K.4400 Radiofrequency lesion generator 2 A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by
the direct application 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 instrument 1 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 instrument 1 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, spat ulas, spoons, blades,
blade holders, blade breakers, probes, etc.
K.4545 Shunt system implantation instrument 1 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 proc edures 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 probe 2 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 flaps by wire or other means.
K.4800 Self-retaining retractor for neurosurgery 2 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 surgery 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 aneurysmorrhaphy 2 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 that provides a visual or auditory signal corresponding to the status of
one or more of a patient's physiological parameters (e.g., brain alp ha wave activity, muscle activity, skin
temperature, etc.) so that the patient 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 catheter 3 An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block
a blood vessel to treat malformations, e.g., aneurysms (balloonli ke 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. The clamp is used to occlude the patient's carotid artery to treat intracranial
aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vasc ular 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 bal loonlike sac formed on a blood vessel), stop bleeding, or hold
tissue or a mechanical device in place in a patient.
K.5235 Aversive conditioning device 2 An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus
to a patient to modify undesirable behavioral characteristics.
K.5250 Burr hole cover 2 A burr hole cover 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 cranioplasty 2 Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surge on 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 shape to repair the defect.
K.5320 Preformed alterable cranioplasty plate 2 A prefor med alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is
constructed of a material, e.g., tantalum that can be altered or reshaped at the time of surgery without changingthe chemical behavior of the material.
K.5330 Preformed nonalterable cranioplasty plate 2 A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and
is constructed of a material, e.g., stainless steel or vitallium 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 t antalum, 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 to be 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 f luid 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 intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central
nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components
intended to facilitate use of the shunt or evaluation of a patient with a shunt.
K.5600 Neurovascular mechanical thrombectomy
device for acute ischemic stroke treatment2 A neurovascular 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 endovasc ular approach, mechanically removes thrombus from the body, and restores
blood flow in the neurovasculature.
K.5800 Cranial electrotheraphy stimulator 3 A cranial electrotherapy stimulator is a device that applies electrical current to a patient's head to treat insomnia,
depression, 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 version of condition- specific behavioral therapy 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 improve 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 magnetic 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 stimulator 2 An external functional neuromuscular stimulator is an electrical stimulator that uses external e lectrodes for
stimulating muscles 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 stimulator 3 An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for thetreatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an
implanted receiver with electrodes that are placed on the patient's cere bellum and an external transmitter 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 stimulation of a patient's
phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have
hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease,
high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with
electrodes that are placed around the patient's phrenic nerve and an external transmitter for transmitting the
stimulating pulses across the patient's skin to the implanted receiver.
K.5840 Implanted intracerebral/subcortical stimulator
for pain relief3 An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to
subsurface areas of a patient 's brain to treat severe intractable 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 paraplegic 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 stimulator 3 An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or
femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg.
The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an
external transmitter for transmitting 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 nerve 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 im planted receiver
with electrodes that are pla ced 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 spinal cord and an external transmi tter for transmitting the stimulating pulses
across the patient's skin to the implanted receiver. Classification: (1) Class 2 for devices intended to treatbody/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 headache 2 An external vagal nerve stimulator for headache is a device used to apply an electrical current to a patient's vagus
nerve through electrodes placed on the skin for the treatment of headache.
K.5893 Thermal vestibular stimulator for headache 2 The thermal vestibular stimulator for headache is a device used to stimulate the vestibular system by applying
thermal waveforms through earpieces placed in a patient's ear canal for the treatment of headache.
K.5895 Vibratory counter-stimulation device 2 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 reduction of withdrawal symptoms associated with substance use disorders.
K.5897 External upper limb tremor stimulator 2 An external upper limb tremor stimulator is a device which is placed externally on the upper limb and designed
to aid in tremor symptom relief of the upper limb.
K.5900 Preformed craniosynostosis strip 2 A preformed craniosynostosis strip 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 fu sed
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 device 3 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 device 3 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 is 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 medical 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 nonsynostotic 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 set 3 The chorionic villus sampling set is a device used to obtain a sample of chorionic tissue through the cervix.
L.0002 Uterine manipulator/injector cannula 2 The uterine manipulator/injector cannula is a device to deliver contrast 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 intended
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 mucus 1 A viscometer for cervical mucus 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 the 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 designed 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 accessories 2 An endometrial suction curette is a device 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 fo r menstrual
extraction. This generic type of 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 fallopian 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-f illed 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'svoluntary contractions of these muscles and is used to diagnose and to correct, through exercise, ur inary
incontinence or sexual dysfunction.
L.1550 Amniotic fluid sampler amniocentesis tray 1 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 gauge 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 abnormalities 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 skin with a short blade and drawing 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 Atransabdominal 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 tissue. This generic type of device may include the following accessories: 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 viewing 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 light source, 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 telescop ic 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, conn ectors, channels, or do not have
portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens
cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), lig ature
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) scissors, and suction/irrigation probe.
L.1660 Transcervical endoscope amnioscope and 2 A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by meansaccessories 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, light sources and cables, and component parts.
L.1690 Hysteroscope and accessories 1,2 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 us ed 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 specialized
instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for
electrosurgical, laser, or other power so urces. 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 filling 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 tub ing/filter fits which only include accessory instruments that are not used to effect intrauterine
access, 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 contains 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 intrauterine tissues.
L.1720 Gynecologic laparoscope and accessories 1,2 Identification: A gynecologic laparoscope is a device used to permit direct viewing of the organs within the
peritoneum by a telescopic system intr oduced 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, scope preheater, light source and cables, and component parts.
Classification: (1) Class 2 ;(2) Class 1 devices for gynecologic laparoscope 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 instruments
include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or
valves), ligature carrier/ne edle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing andknotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps,
dissector, mechanical (noninflatable), scissors, 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 a nalyze electronic signal
data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal
status and recommendations for labor management and clinical interventions. This generic type of device may
include si gnal analysis and display equipment, electronic interfaces for other equipment, and power supplies and
component parts.
L.2225 Obstetric-gynecologic ultrasonic imager 2 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: signal 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 use d to monitor the changes in some physiological condition 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 fe tal 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 de vice may include an alarm that signals when the heart
rate crosses a preset threshold. This generic type of device includes the "fetal cardiotachometer (with sensors)"
and the "fetal electrocardiographic monitor."
L.2620 Fetal electroencephalographic monitor 3 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 produced by the fetal brain.
L.2640 Fetal phonocardiographic monitor and
accessories2 A fetal phonocardiographic 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 accessories: signal analysis and display equipment, patient and equipment
supports, and other component parts.L.2660 Fetal ultrasonic monitor and accessories 2 A fetal ultr asonic 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 characteristic in a mea sured value over a period of time (e.g., perinatal
monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This
generic type of device may include the following accessories: signal analysis and display equi pment, electronic
interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device
does not include devices used to image some relatively unchanging physiological structure or interpret a
physiological condit ion, 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 and delivery. It establishes electrical contact between fetal skin and an external 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 applicator 3 A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin
and an external monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used
to obtain a fetal electrocardiogram. This generic type of device may include a clip electrode applicator.
L.2700 Intrauterine pressure monitor and accessories 2 An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid
pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity,
duration, and frequency of uter ine contractions during labor. This generic type of device may include the
following accessories: signal analysis and display equipment, patient and equipment supports, and component
parts.
L.2720 External uterine contraction monitor and
accessories2 Anexternal uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of
labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped
to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps,
and other patient and equipment supports.
L.2730 Home uterine activity monitor 2 A home uterine activity monitor (HUAM) is an electronic system for at home antepartum meas urement of uterine
contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine
contraction data at the clinic. The HUAM system comprises a tocotransducer, an at- home recorder, a modem,
and a computer and m onitor 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 accessories 2 A perinatal monitoring system is a device used to show graphically the relationship between maternal labor andthe fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with
appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of
device may include the following accessories: Central monitoring system and remote repeaters, signal analysis
and display equipment, patient and equipment supports, and component parts.
L.2800 Computerized Labor Monitoring System 2 A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal
head descent and provide a display that indicates the progress of labor. The computerized labor monitoring
system includes a monitor and ultrasound 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 not only through sound channels by air conduction, but also through the user's head by tissue conduction
into the user's ears. It does not use ultrasonic energy. Th is device is designed to eliminate noise interference
commonly caused by handling conventional stethoscopes.
L.2960 Obstetric ultrasonic transducer and accessories 2 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 electrical 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 accessories: coupling gel, preamplifiers, amplifiers, signal conditioners
with their 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 variations of the surface of the body. This generic type
of device may include signal analysis and display equipment, patient and equipment support s, component parts,
and accessories. Classification: (1) Class 1 devices intended for adjunctive diagnostic screening 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 system 1,3 (a)A nonelectrically powered or an AC- powered liquid crystal 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 physical 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 that respond to temperature variations of the surface of the body. This generic type of device may includepatient and equip ment supports, a means to ensure thermal contact between the patient's skin and the liquid
crystals, component parts, and accessories. (2) Classification. Class 1.
(b) A nonelectrically 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 a nonelectrically 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 gener ic type of device may include image 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 maintai n the patency (openness) of the fallopian tube and is
used after reconstructive surgery.
L.3900 Vaginal stent 2 A vaginal stent is a device 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 containment system is a device consisting of an instrument port
and tissue containment method that creates a working space allow ing 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 accessories 2 An endoscop ic 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 accessories 2 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 observation. 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 tissue between two electrical contacts of a probe. This generic type of device may
include the following 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 high frequency electrical current through the tissue between an energized probe and a grounding
plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This
generic type of device may include the following accessories: an electrical generator, probes and electrical
cables, and a patient grounding plate. This generic type of device does not include 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 manua lly to
dilate (stretch open) the cervical os.
L.4260 Hygroscopic Laminaria cervical dilator 2 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 device 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 the birth canal) by means of a suction cup attached to the scal p and is powered by an external
vacuum source. This generic type of 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 instrument 2 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 manipula tive functions. This generic type of device consists of the following:(1) Anepisiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the
vulvar orifice for obstetrical purposes.(2) A fiberoptic metal vag inal 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 instrum ent, 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 introduce dressing into the uterus or
vagina.(7) A vaginal appli cator is an instrument used to insert medication into the vagina.(8) A vaginal retractor
is an instrument used to maintain vaginal exposure 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 structural 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 peni s 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-
size cervical dilator is any of a serie s 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 forceps is an instrument with two bla des 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 used t o 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 forcep s 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 mea sure 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 fiberopticnonmetal 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 tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a
gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.
L.4900 Obstetric table and accessories 2 An obstetric table is a device with adjustable sections designed to support a patient in the various positions
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 system 3 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 anesthesia 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 pudendal) that may be used during labor, delivery, or both.
L.5200 Hemorrhoid prevention pressure wedge 2 A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor
and delivery process. External mechanical s upport of the perianal 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 chamber 3 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 c ap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificialinsemination. 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 membrane. The condom is used
for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The
device may also be used to collect semen to aid in the diagnosis of infertility. The devic e may contain lubricants
compatible for use with condoms.
L.5310 Condom with spermicidal lubricant 2 A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting
membrane with a lubricant 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 immediate 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 condom 3 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 (preventing 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 vagi na or anus prior to the initiation 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 accessories 2 A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone
and the posterior 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 fundus with a string extending from 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 contraceptive 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 to 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 u sed to soothe or to help heal the
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 inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e.,
fragrance materials) added for aesthetic 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 tampon 2 An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted
into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of de vice does not
include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents
or other drugs.
L.5900 Therapeutic vaginal douche apparatus 1,2 Identification: A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle.
The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment
of medical conditions except it is not for contraceptive use. After filling the therape utic 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 strength 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 use 2 A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use
in the treatment of sexua l 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 fo r use in the treatment
of female sexual 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 needles 2 Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer(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 si ngle or
double lumen needle and component parts, including needle guides, such as those used with ultrasound.
L.6110 Assisted reproduction catheters 2 Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer
(GIFT), or other assisted reproduction 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 accessories 2 Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in
conjunction with assisted reproduction needles and/or assisted reproduction cathete rs, to aspirate, incubate,
infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used
to provide low flow, intermittent vacuum for the aspiration of eggs (ova).(2) Syringe pumps (powered or manual)
used t o activate a syringe to infuse or aspirate small 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 st age warmer is a device used to maintain the temperature 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 c ontain, freeze, and maintain
gametes and/or embryos at an appropriate freezing temperature.
L.6130 Assisted reproduction microtools 2 Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate,
hold, or transfer 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, bevel, 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 micromanipulators 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 assisted reproduction microtool.
L.6160 Assisted reproduction labware 2 Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store,
manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer
(GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue
culture plates, pipette tips, dishes, plates, and other vessels that come into physical con tact 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 and water
purification systems2 Assisted reproduction water purification systems are devices specifically intended to generate high quality,
sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage 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 assisted 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 supplements 2 Reproductive media and supplement are products that are used for assisted reproduction procedures. Media
include liquid and powder versions o f various substances that come in direct physical contact 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 purpo ses of preparation, maintenance,
transfer or storage. Supplements 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 accessories (excluding microscope stage warmers, which
are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes
or embryos. Variations of microsc opes and accessories used for these purposes would include 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 are multiple embryos deemed suitable for transfer or freezing.
L.6200 Assisted reproduction laser system 2 The assisted 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 assisted 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 system 3 Ophthalmic excimer laser system is intended for corneal ablation (i.e., photorefractive keratectomy) and other
ophthalmologic procedures (e.g., surgical creation of a communication betwe en the lacrimal sac and the nasal
cavity). It includes a light source, controls/foot-switch, monitoring system, and probes. This system commonlyconnects to a slit lamp or non-contact ophthalmoscope by an optical fiber.
M.0002 Endocapsular ring 3 Anendocapsular ring is an ophthalmic device for placement into the 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 pun ctum 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 d isplaying mixed
spectral lines to be matched by the patient.
M.1090 Haidlinger brush 1 A Haidinger brush is an AC- powered device that provides two conical brushlike 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 measuring macular integrity.
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 which a patient is to sit
or recline during ophthalmological examination or treatment.
M.1160 Color vision plate illuminator 1 A color vision plate illuminator is an AC- powered device that is a lamp intended to properly illuminate color
vision testing plates. 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 c overing the fovea
(the central depression of the macular retinae where 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 intended 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 center 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 w hich 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 directional 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 creating
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 k eratoscope 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 notobscure visualization of objects. The device is placed in a trial frame and intended to determine
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 ophthalmoscopy (a procedure that produces
an inverted or reversed direct magnified image of the eye) intended to focus reflected light f rom the fundus of
the eye.
M.1385 Polymethylmethacrylate (PMMA) diagnostic
contact lens2 A polymethylmethacrylate (PMMA) diagnostic 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 lens 1 A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of
increasingly r efractive 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 lens 1 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 intended to 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 ha ndheld
or inserted 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 device 1 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 instrument 1 Astereopsis measuring instrument is a device intended to measure depth perception by illumination of objects
placed on different 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 opticsintended 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 patient. 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 photostimulator 2 An AC-powered photostimulator is an AC- powered device intended to provide light stimulus which 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
from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after
stimu lation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in
the front and the back of the eyeball), 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 measure 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 may 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 deviation in patients with latent or manifest strabismus (eye muscle deviation).
M.1670 Ophthalmic isotope uptake probe 2 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 as 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 syst em, 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 eye 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 rays. 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- powered device that is a large square cloth chart
with a central mark of fixation intended to map on a f lat 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 biomicroscope 2 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 intended 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 strip 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 system 1 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 system 2 A diurnal pattern recorder system is a nonimplantable, device incorporating a telemetric sensor to detect changesin ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
M.1930 Tonometer and accessories 2 A tonometer and acce ssories is a manual device intended to measure intraocular pressure by applying a known
force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure
intraocular tension by applanation (applying a small flat di sk to the cornea). Accessories for the device may
include a tonometer calibrator or a tonograph recording 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-power ed 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 together 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 d evice usually made of molded plastic intended to be inserted temporarily between
the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing
process following surgery.
M.3200 Artificial eye 1 Anartificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended
to be inserted 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 contents of the eyeball with the sclera left intact.
M.3340 Extraocular orbital implant 2 An extraocular orbital implant is a nonabsorbable device int ended to be implanted during scleral surgery for
buckling or building 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 provi de a transparent optical pathway through an opacified cornea,
either intraoperatively 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 lens 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 scle ra for cosmetic or reconstructive purposes. An artificial eye is usually paintedon 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- powered 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 surgery to
coagulate tissue or arrest bleeding by heat conducted through a wire tip.
M.4150 Vitreous aspiration and cutting instrument 2 A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound,
intended to remove 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 procedure. These plugs prevent intraocular 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 cryo phthalmic 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 device 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
performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from
surgical trauma, or function as a tamponade during retinal reattachment.
M.4280 Intraocular pressure measuring device 3 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 intraocular 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 instrument 1 A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform
ophthalmic surgical procedures. This generic type of device includes th e manual corneal burr, ophthalmic caliper,
ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic
curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, op hthalmic
hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe,
cornea- sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic
scissors, enucleating snare, oph thalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud,
trabeculotome or ophthalmic manual trephine.
M.4360 Ocular surgery irrigation device 1 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 capsulotomy 2 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 short pulse, low energy, high power, cohere nt 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 invisible Nd:YAG laser radiation on or in clos e 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 scleral 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 dialindicator, 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 device 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 extended
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 to protect the
eye 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 source 2 An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant
ocular growths.
M.5200 Eyelid thermal pulsation system 2 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, including meibomian gland dysfunction (MGD), also known as evaporative dry eye
or lipid de ficiency 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 device 2 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 devic e
intended to increase tear production for improvement in dry eye symptoms.
M.5350 Ultrasound cyclodestructive device 2 Ultrasound cyclodestructive device is a device that reduces the intraocular pressure by generating a series of
lesions caused by high-i ntensity 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 mounted 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 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 le ns include corrective and protective sports goggles, such as
swimmers’ goggles, ski goggles, racquetball eye guards, and diving goggles.
M.5905 Oral electronic vision aid 2 An oral electronic vision aid is a battery-powered device that contains an electro de stimulation array to generate
electrotactile 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 lens 2,3 A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct
vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-
silicone, or silicone elastome rs, 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 products 1,2 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 includes all solutions and tablets used
together with rigid gas permeabl e contact lenses. Classification: (1) Class 1 contact lens container. ;(2) Class 2
other devices.
M.5925 Soft (hydrophilic) contact lens 2,3 A soft (hydrophilic) contact lens is a device 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 m ain polymer molecules of which absorb or attract 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 products 1,2 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 inc ludes all solutions and tablets used
together with 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 centralcompetent health authority.
N.0001 Orthopedic extracorporeal shock wave system 3 An orthopedic extracorporeal shock wave therapy system is a therapy system for orthopedic diseases.
N.0003 Intraarticular hyaluronic acid implants 3 Intra-articular hyaluronic acid implants are hyaluronic acid used for intra-articular injections.
N.0004 Inflatable bone expander system 2 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 formin g pores
inside the cancellous bone of spine, hand, tibia, radius and calcaneus.
N.1100 Arthroscope 1,2 An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The
arthroscope and accessories also is intended t o perform surgery within a joint. Classification: (1) Class 1 for the
following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives,
obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, sut ure 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 inten ded 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 molecu lar 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 (adult) 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 rod 2 An in vivo cured intramedullary fixation rod is a implanted device consisting of a balloon that is inserted into
the medullary canal of long bones for the fixation of fractures. The balloon is infu sed 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 intended 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 growt h of a new tendon sheath. The device
is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function
as a scaffold for soft tissue ingrowth.
N.3027 Polymethylmethacrylate (PMMA) bone
cement2 Polymethylme thacrylate (PMMA) bone cement is a device intended to be implanted that is made from
methylmethacrylate, polymethylmethacrylate, 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 metallic 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 of one or more metallic components 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 di stal
end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures 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 segment 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, s lotted head on the end. It may be used for fixation of bone fractures, for bone
reconstructions, as a guide pin for 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 device 2,3 A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps ofthe extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the
bony structure. Classification: (1) Class 2 devices do not contain medicine. (2) Class 3 devices contain medicine.
N.3050 Spinal interlaminal fixation orthosis 2 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 s pine to allow bone grafts
to unite and fuse the vertebrae together. The device is 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 orthosis 2 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 inserted
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 or crimped at each eye- type screw. The device is used to
apply force to a series of vertebrae 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 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al- 4V , and unalloyed
titanium, that allow the surgeon t o 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, sleeve s, 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 skeleta lly mature
patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of
the thoracic, lumbar, and sacral spine: severe spondylolisthesis of vertebra; degenerative spondylolisthesis with
objective evid ence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed
previous fusion pseudarthrosis.
N.3075 Posterior cervical screw system 2 Posterior cervical screw systems are comprised of multiple, interconnecting com ponents, 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 screws (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 dualdiameter 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 rigidly 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 seg ments 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 traumatic dislocations, deformities,
instabilities , failed previous fusions (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 following decompression to treat radiculopathy
and/or myelopathy.
N.3080 Intervertebral body fusion device 2,3 An intervertebral body fusion device is an implanted single or multiple component spinal device made from a
variety of materials, including titanium 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 t hat contain bone grafting material. (2) Class 3
for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein)
N.3100 Ankle joint metal/composite semi-constrained
cemented prosthesis2 An ankle joint metal/composite semi- constrained cemented prosthesis is a device intended to be implanted to
replace an ankle 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-jo int. This generic type of device 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 f ibers 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 joint. The device limits translation and rotation in one or more planes via the geometry of its
articulating surfaces and has no linkage 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 lim ited 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 j oint. 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 tibialcomponent 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 intended 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 bus hing. The device prevents dislocation in more than one anatomic plane
and consists of two components that are linked together. 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 implanted 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 linkage across-the- joint. This generic type of device includes prostheses that
consist of a humeral resurfacing 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 prost hesis is a device intended to be implanted made
of alloys, such as cobalt-chromium- molybdenum, that is used to replace the distal end of the 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 constrained uncemented prosthesis is a device intended to be implanted to replace a
metacarpophalangeal or proximal in terphalangeal (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 made of alloys, such as cobalt-chromium-molybdenum, or p rotheses 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
metacarpophalangeal (finger) joint. This device prevents 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 3 A fin ger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace acemented prosthesis metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than
one anatomic plane, and consists of two c omponents which are linked together. This generic type of device
includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and ultra- high molecular
weight polyethylene, and is limited to those prostheses intended for use with bone cement.
N.3230 Finger joint polymer constrained prosthesis 2 A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a
metacarpophalangeal 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 ana tomic 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-molybdenum, and is intended for use with or without bone cement. This device is not inten ded 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 generic t ype 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 articulating 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. This generic type of device is limited to those prostheses intended for use with b one
cement.
N.3330 Hip joint metal/metal semi-constrained, with
an uncemented acetabular component,
prosthesis3 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 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 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 acetabularcomponent 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 generic 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 polyeth ylene 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 imp lanted 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 articulating 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 wit h
or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures
positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral 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 uncemented 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 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 50 0 and 1,500 microns. The generic type ofdevice has a design to achieve biological fixation to bone without the use of bone cement.
N.3360 Hip joint femoral(hemi-hip) metallic
cemented or uncemented prosthesis2 A hip joint femoral (hemi-hip) metallic ce mented or uncemented 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
component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs
which are intended to be fixed to the 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 ge neric type of device includes
prostheses that consist of a metallic 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.
Thehead of the device is made of polyacetal (polyoxymethylene) and 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
have 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 wei ght
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 de vice 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 transl ation 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 consist of afemoral cap component made of a metal alloy, such as cobalt-chromium- molybdenum, or a ceramic 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 linke d 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 joine d either by a solid bolt 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 j oint. 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 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 femorotibial 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 affined. 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-soc ket joint is composed of a ball 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 held 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 femoralcomponent and fl anges on 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 femo ral 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 passing
through a journal bearing 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)
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 component or components made of ultra-high molecu lar 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 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 surfaces. It has no linkage across-the- joint. This generic type of device includes
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 translatio n 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 includ es
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 limits translation and rotati on 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 interco ndylar 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 dev ice 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 together. This generic type of device includes prostheses that have a femoral
component, a tibial compo nent, 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 retropatellar surfacing component ma y be attached to the resected patella either with
a metallic screw or bone cement. All stemmed metallic components within this generic type are intended 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 plane s
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 components 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 high molecular w eight 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 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 component with or without
protuberance(s) for the enhancement of fixation and is limited to those prosth eses intended for use without bone
cement.
N.3580 Knee joint patellar (hemi-knee) metallic 2,3 A knee joint patellar (hemi- knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such asresurfacing uncemented prosthesis cobalt-chromium- molybdenum, intended to be implanted to replace the retropatellar articular surface 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. Clas sification: (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 resurfacing uncemented prosthesis is a device intended to be implanted
to replace part of a knee joint. The device limits minimally (less than normal anatomic constraint s) translation
in one or more planes. It has no 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
components that are linked together. Thi s 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 molecular weight polyethylene. This gene ric 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 prosthesis 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 linkage 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 planes via the geometry o f 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 2 A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous- coated uncemented prosthesisnonconstrained or semiconstrained porous-
coated uncemented prosthesisis 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 i ncludes 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 designed 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 with 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 implanted 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 prosthesis 2 A toe joint polymer constrained prosthesis is a device made of si licone 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 prosthesis 2 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 polymer prosthesis 2 A wrist joint carpal scaphoid polymer prosthesis is a one- piece device made of silicone elastomer intended to be
implanted to replace the carpal scaphoid bone of the wrist.N.3770 Wrist joint carpal trapezium polymer prosthesis 2 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 prosthesis 2 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.
The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-
the-joint component or two co mponents 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 be 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 linkage 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 de vices 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 surface 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 me asuring the thickness or diameter of a
part of the body or the distance between two body surfaces, such as for measuring 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 use 1 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 evacuator 1 A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirablefumes, 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 the release of air or fluid from the cavity as it is being filled with bone cement
N.4300 Depth gauge for clinical use 1 A dep th gauge for clinical use is a measuring device intended for various medical purposes, such as to determine
the proper length of screws for fastening the ends of a fractured bone.
N.4540 Orthopedic manual surgical instrument 1 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 holder, impactor, bending or contouring instrument, compression
instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, ron geur, scissors,
screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, 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 use 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 nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonp owered 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 component 1 A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does
not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic
pulling force may be applied to the patient's body.
N.5940 Cast component 1 A cast compone nt 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 1 A manual cast application and removal instrument is a nonpowered hand- held device intended to be used ininstrument 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 apparatus 2 A static electric 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, rectification circuit, electrodes, and insulators. The device uses safety circuit
to limit its output current and creates a voltage of approximately 600 to 10,000 volts.
O.0002 Non-invasive bone growth stimulator 3 The non-invasive bone growth stimulator is a non- invasive 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 system 2 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 Device 1 Continuous passive motion device is to move a specific joint of the patient through the designed range of motions
without applying force. This device aids patients, who suffer joint replacement surgery or with neurological
disease, to increase the range of joint motion.
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, for the diagnosis and prognosis of neuromuscular disease.
O.1385 Diagnostic electromyograph needle electrode 2 A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted i nto
muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in
connection 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 appli ed upon aplanar surface into analog mechanical or electrical signals. This device is used to determine ground reaction
force, centers of percussion, centers of torque, and their variations in both magnitude and direction with time.
O.1600 Intermittent pressure measurement system 1 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 transducer 1 A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a
device and soft tissue by converting mechanical inputs to analog electrical signals.
O.1850 Diagnostic muscle stimulator 2 A diagnostic muscle sti mulator is a device used mainly with an electromyograph machine to initiate muscle
activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders
and neuromuscular function.
O.1925 Isokinetic Testing and Evaluation System 1 An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes,
such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.
O.3025 Prosthetic and orthotic accessory 1 A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the
use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the
following: A p elvic 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 canes 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 e levating seat used to raise a person from a sitting
position to a standing position and 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 wi th 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
weight 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, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seatto lessen the likelihood of skin ulcers.
O.3410 External limb orthotic component 1 An external limb orthotic component is a device intended for medical purposes for use in conjunction with an
orthosis (brace) to increase the function 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 component 1 An external limb prosthetic component is a device intended for medical purposes that, when put together with
other appropriate components, constitutes a total prosthesi s. Examples of external limb prosthetic components
include the following: Ankle, foot, 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
intende d for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent
upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as
switches) to provide greater than two independent and simultaneously 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 t otal upper extremity prosthesis
system.
O.3475 Limb orthosis 1 A limb orthosis (brace) is a device intended for medical 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 exoskeleton 2 A powered lower extremity exosk eleton 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 the 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 prosthesis 1 An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a
preassembled external artificial limb for the lower extremity. Examples of external asse mbled 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 treatment or examination.O.3610 Rigid pneumatic structure orthosis 3 A rigid pneumatic structure orthosis is a device intended for medical purposes to provide whole body support
by means of a pressurized suit to help thoracic paraplegics walk.
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.
O.3665 Congenital hip dislocation abduction splint 1 A congenital hip dislocation abduction splint is a device intended 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
useby 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 medical 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 upright 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 adjusted 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 purposes 2 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 to persons 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- operated 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 external 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 topersons restricted 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 d evice 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) Providing 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 req uired 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.5100 Immersion hydrobath 2 An immersion hydrobath is a device intended for medical purposes th at consists of water agitators and that 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 itching and as an aid in the healing process of inflamed and traumatized tis sue,
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 e xternal 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 me dical 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. Cl assification:
Class 2.
(b) Devices that 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, roundceramic objects) that is intended for medical purp oses to treat or prevent bedsores, to treat severe or extensive
burns, or to aid circulation.
O.5170 Powered flotation therapy bed 1 A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of
constantly mo ving 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 intended 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 body 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 relief 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 treatment of 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 heat 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 megaher tz 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 treatment of malignancies. (2)Classification: Class 2.
(b)Shortwave diathermy for all other uses -- (1)Identification: A shortwave diathermy for all other uses exceptfor 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 megaher tz 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.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 bod y 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 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 frequ ency beyond
20 kilohertz 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.5360 Measuring exercise equipment 2 Measuring exercise equipment consist of manual devices intended for medical 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 use d 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 specified uses 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 massager 2 A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor
muscle aches and 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 pack 1 A cold pack is a device intended for medi cal 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 therapy for body surfaces.
O.5710 Hot or cold disposable pack 1 A hot or cold disposable pack is a device intended 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 pack 1 A water circulating hot or cold pack is a device intended 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 Apowered heating pad is an electrical device intended for medical purposes that provides dry heat 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 tissues 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 an 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 stimulator 2,3 (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 therape utic 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 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 treatment 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 kilohe rtz and applies to the body electrical currents and that is intended
for the treatment of medical conditions by means other than the generation of deep heat within body tissuesand the stimulation or relaxation of muscles as described in paragraph (a) of t his section. (2) Classification:
Class 3.
O.5880 Multi-function physical therapy table 2 A multi- function physical 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 powered 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 accessory device intended for medical purposes to be used with powered
traction equipment to aid in exerting therapeutic pulling forces on t he 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 radiation blood irradiator is a device that generates ionizing radiation to irradiate blood and blood
products (blood packs), making the ly mphoid cells in the blood deactivate for the prevention of graft versus host
disease (GVHD).
P.1000 Magnetic resonance diagnostic device 2 A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect
the sp atial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei
exhibiting nuclear magnetic 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) camera 1 A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by
means of a photon radiation detector. This generic 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, pa tient 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 type 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 minera l content byx-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 that indicate overall bone health and fracture risk. The primary components of the device are
a voltage generator, a transmi tting transducer, a receiving transducer, and hardware and software for reception
and processing of the received ultrasonic signal.
P.1200 Emission computed tomography system 2 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 through 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 fluorescent 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 detector (or detectors) whose position moves in two directions 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 signal 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 and equipment supports, component parts, and accessories.
P.1330 Nuclear whole body scanner 1 A nuclear 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 system 2 A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide
or a radionuclide-labe led aerosol and permit it to be respired by the patient during nuclear medicine ventilatory
tests (testing process of exchange between the 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 source 1 A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended
for calibration of medical nuclear radiation detectors.
P.1410 Nuclear electrocardiograph synchronizer 1 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 wave into body tissue
other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is inten ded for use in
the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device
may include signal analysis and display equipment, patient and equipment supports, component parts, and
accessories.
P.1550 Ultrasonic pulsed doppler imaging system 2 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 tissu e
characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of
blood or tissue motion. 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 system 2 An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue
to determine the depth or location of the tissue interfaces and t o measure the duration of an acoustic pulse from
the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal
analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1570 Diagnostic ultrasonic transducer 2 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 this generic type of device may include transmission media for acoustically
coupling the transducer 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, orlymphatic 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 device 2 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 camera 2 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 system 2 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 signal
analysis and display equipment, patient and equipment supports, component parts, and accessories.
P.1640 Radiographic film marking system 1 A radiographic film marking system is a device intended for medical purposes to add identification and other
information onto radiographic film by means of exposure to visible light.
P.1650 Image-intensified fluoroscopic x-ray system 2 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 incl ude 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 equipment supports, component parts, and accessories.
P.1700 Diagnostic x-ray high voltage generator 1 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 system 2 A mammographic x- ray system is a device intended to be used to produce radiographs of the breast. This generictype of device may include signal analysis and display equipment, patient and equipment supports, component
parts, and accessories.
P.1715 Full-field digital mammography system 2 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, ima ge processing and reconstruction
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
diagn ostic procedures. This generic type of device may include signal analysis and display equipment, patient
and equipment supports, component parts, and accessories.
P.1730 Photofluorographic x-ray system 2 A photofluorographic x-ray system is a device that includes a fluoroscopic x- ray 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 equipment, 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 include signal analysis and display equipment, patient and equipment supports, component parts, and
accessories.
P.1750 Computed tomography x-ray system 2 A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross- sectional images
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 assembly 1 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 high voltage and filament
transformers or other appropriate components.
P.1820 Pneumoencephalographic chair 2 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 aradiographic 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 changer 2 A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a
radiographic film 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 cassette changer during serial medical radiography.
P.1900 Automatic radiographic film processor 2 An automatic radiographic film 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 radiopaque 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 screen 1 A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material
that transforms incident x- ray photons into visible light and intended for medical purposes to expose radiographic
film.
P.1970 Radiographic ECG/respirator synchronizer 1 A radiographic ECG/respirator synchronizer is a device intended to be used tocoordinatean x-ray film e xposure
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 evaluation 3 A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses
low intensity 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 device 1 A medical image storage 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 device 1 A medical image communications device provides electronic transfer of medical image data between medical
devices. It may include a physical communications medium, modems, interfaces, and a communications
protocol.
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 Iystems employing video frame grabbers, and scanners which use lasers or charge- coupled
devices.
P.2040 Medical image hardcopy device 2 A medical image hardcopy device is a device that produces a visible printed record of a medical image and
associated identification information. Examples include multiformat cameras and laser printers.
P.2050 Picture archiving and communication system 2 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, or
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.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) intended 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 system 2 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 equip ment
support, treatment planning computer programs, component parts, and accessories.
P.5650 Manual radionuclide applicator system 1 A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source
into the body or 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 radionuclide 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 ge neric type of device may include patient and equipment supports, component parts,
treatment planning computer programs, and accessories.
P.5710 Radiation therapy beam-shaping block 2 A radiation therapy beam-shaping block is a device made of a highly atte nuating material (such as lead) intended
for medical purposes to modify the shape of a beam from a radiation therapy source.
P.5720 Rectal balloon for prostate immobilization 2 A rectal balloon for prostate immobilization is a single use, inflatable, non- powered positioning device placed
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 anteriorrectal wall away from the prostate during radiotherapy for prostate cancer with the int ent 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 absorbed by the patient's body over time.
P.5730 Radionuclide brachytherapy source 2 A radionuclide brachytherapy 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 source 1 A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The
device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
P.5750 Radionuclide radiation therapy system 2 A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation
therapy, with the radiation source located 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 patient during radiation therapy.
P.5780 Light beam patient position indicator 1 A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to
determine the 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 system 2 A radiation therapy simulation system is a fluoroscopic or radiographic x- ray system intended 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 an alysis and display
equipment, patient and equipment supports, treatment planning computer programs, component parts, and
accessories.
P.5900 X-ray radiation therapy system 2 An x-ray radiation therapy system is a device intended to produce and control x-r ays 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 assembly 2 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, orother persons from unnecessary expos ure 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 this classification and specified by the central
competent health authority.