1 
 Regulations Governing  
the Classification of Medical Device s (Draft)   
 
Article 1  These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical  
Devices Act (hereinafter “this Act”).  
 
Article 2   Medical devices are classified into the following categories according to their 
function, intended use, operating instruction s, and working principle,  depending 
on the applicable medical specialt y: 
1. Clinical chemistry and clinical toxicology devices  
2. Hematology and pathology devices  
3. Immunology and microbiology device s 
4. Anesthesiology devices  
5. Cardiovascular devices  
6. Dental devices  
7. Ear, nose, and throat devices  
8. Gastroenterology a nd urology devices  
9. General and plastic surgery 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  
 
  
2 
 Article 4  Product i tems of the medical device classificati on are specified  in the Annex.  
In addition  to rules stated in the Annex , medical device s whose  function, intended 
use, or working principle are special may have their classification determined  
according to the following  rules : 
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 medic al device , is classified the same as the particular 
medical device,  unless otherwise specified in the Annex . 
3. The clas sification 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 m edical device containing medicine while having the primary mode of 
action  of a medical device  is determined to be a Class III  medical device , 
unless otherwise specified in the Annex . 
 
Article 5  Medical device firms or the public may make an inquiry to the central competent 
authority regarding classification of medical devices or other relevant matters.  
Inquirer s 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  separately .  
2. Other reference  information : Reference information from the United State s 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.  
  
3 
 Article 6  If the function, intended use, or working principle of the medical device does not 
meet identification criteria of the product items listed in the Annex, its 
classification shall be determined to be a Class III medical device. However, if a 
similar product h as received license or been listed domestically, its classification 
shall be determined according to the risk level of the similar product, 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  These Regulations shall enter into force from the effective date of this Act. 
  1/222 
 Annex  
Classification 
Number  Classification 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 function in an assay that is used for the 
qualitative and/or quantitative determination of electrolytes and other ions in a clinical specimen.  
A.1020  Acid phospha tase (total or prostatic) test 
system  2 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 system  2 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 the adrenal glands such as Cushin g's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.  
A.1030  Alanine amino transferase (ALT/SGPT) 
test system  1 An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme 
alanine ami no 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 o r 
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, 
selective hypoaldosteronism, edematous states, and other conditions o f electrolyte imbalance.  
A.1050  Alkaline phosphatase or isoenzymes test 
system  2 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 liver, bone, parathyroid, and intestinal 
diseases.  2/222 
 A.1055  Newborn screening test system for amino 
acids, free carnitine, and acylcarniti nes 
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 intended for the 
measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole 
blood filter paper samples.  The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their 
relationship with each other provides analyte concentration profiles that may aid in screening newborns for one or 
more inborn errors of amino acid, free carnitine, and  acyl-carnitine metabolism.  
A.1060  Delta -aminolevulinic acid test system  1 Adelta -aminolevulinic acid test system is a device intended to measure the level ofdelta -aminolevulinic acid (a 
precursor of porphyrin) in urine.Delta -aminolevulinic acid measur ements are used in the diagnosis and treatment 
of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are 
accompanied by increased urinary excretion of various heme compounds includingdelta -amino levulinic 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. Adrostenedione measu rements 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 adrosterone 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 angioten sin I generated by renin 
in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.  
A.1090  Angiotensin converting enzyme (A.C.E) 
test system  2 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 obtained by this device are used in the diagnosis and 
treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, 
and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.  
A.1095  Ascorbic acid test system  1 An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, 
serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary 
deficiencies.  3/222 
 A.1100  Asparate amino transferase (AST/SGOT) 
test system  2 An aspartate amino transferase (AST/SGOT) test system is a device intended to measu re the activity of the enzyme 
aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum 
and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of 
liver and heart disease.  
A.1110  Bilirubin (total or direct) 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 treatment of liver, hemolytic hematological, 
and metabolic disorders, including hepatitis and gall bladder block.  
A.1113  Bilirubin (total a nd unbound) in the 
neonate test system  1 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 bilirub in encephalopathy 
(kernicterus).  
A.1115  Urinary bilirubin and its conjugates 
(nonquantitative) test system  1 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 diagn ostic 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 devic e 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 dietar y 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 system  2 A blood gases (PCO2, PO2) and blood pH test system is a device intended to  measure certain gases in blood, 
serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, 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 erythro cyte 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 a re used in the diagnosis and treatment of patients 
with abnormal insulin secretion, including diabetes mellitus.  4/222 
 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 measurements are 
used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and 
tetany (interm ittent 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 system  2,3 (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 in tended for the early detection 
of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. (2)Classification: Class 2.  
(b)Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy 
--(1)Identification: A human chorionic goadotropin (HCG) test system is a device intended for any uses other than 
early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons 
with certain tumors or carcinoma s) 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 plasm a, 
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  system  2 A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) 
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) teset system  1 A catecholamines (total) test system is a device intended to determine wheth er a group of similar compounds 
(epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are 
used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine -secreting  
tumors (pheochromo -cytoma, 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.  5/222 
 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 t o measure the bile acid cholylglycine in serum. Measurements 
obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive 
liver disease.  
A.1180  Chymotrypsin test system  1 A chymotrypsin test system 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 -deoxycortiso l) 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 com pound 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 system  2 A conjugated sulfolithocholic  acid (SLCG) test system is a device intended to measure the bile acid SLCG in 
serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as 
cirrhosis or obstructive liver disease.  
A.1190  Copper test system  1 A copper test system is a device intended to measure copper levels in plasma, serum, and urine. Measurements of 
copper are used in the diagnosis and treatment of anemia, infections, inflammations, and Wilson's disease (a 
hereditary disease primari ly 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 p lasma. 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 disturbanc es. 
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 system  2 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.  6/222 
 A.1210  Creatine test system  1 A creatine test system is a device intended to meas ure 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 hyperthyroidi sm. 
A.1215  Creatine phosphokinase/ creatine kinase 
or isoenzymes test system  2 A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of 
the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in 
plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and 
treatment of myocardial infarction and muscle diseases such as progressive, Duchenne -type muscular dys trophy.  
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 resu lts are intended to be 
used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, 
including confirmation by alternative methods.  
A.1225  Creatinine test system  2 A creatinine test system is a device  intended to measure creatinine levels in plasma and urine. Creatinine 
measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a 
calculation basis for measuring other urine analytes.  
A.1230  Cyclic AMP t est 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 diagnosis and treatment of Graves' disease (a disorder of the thyroid) and 
in the differentiation of causes of hypercalcemia (elevated le vels of serum calcium.)  
A.1235  Cyclosporine test system  2 A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid 
in the management of transplant patients receiving therapy with this drug. This gen eric type of device includes 
immunoassays and chromatographic assays for cyclosporine.  
A.1240  Cystine test system  1 A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are 
used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop 
kidney calculi (stones).  
A.1245  Dehydroepiandrosterone (free and 
sulfate) test system  1 A dehydroepiandrosterone (free and sulfate) test system is a device intended t o measure dehydroepiandrosterone 
(DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are 
used in the diagnosis and treatment of DHEA -secreting adrenal carcinomas.  
A.1250  Deoxycorticosterone test system  1 A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and 
urine. DOC measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism 
(excess retention of sodium and loss of potassium) and other disorders of the adrenal gland.  7/222 
 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 are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing 
placental function in complicated pregnancy.  
A.12 65 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 pregnancy) test system is a device intended to measure total estrogens in plasma, serum, 
and urine during pregnancy. The device primarily me asures 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 a nd 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. Estrone 
measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, 
differentiation of primar y 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 urin e. 
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 devic e intended to measure the vitamin folic acid in plasma and serum. Folic acid 
measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the 
presence of megaloblasts (an abnormal red blood cell series) in the bon e marrow.  8/222 
 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 system  2 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 
galactos e metabolism) in infants.  
A.1320  Gastric acidity test system  1 A gastric acidity test system is a device intended to measure the acidity of gastric fluid. Measurements of gastric 
acidity 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. Mea surements 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 diso rders of blood globulins.  
A.1335  Glucagon test system  1 A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. 
Glucagon measurements are used in the diagnosis and treatment of patients with various diso rders 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 u rine). 
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, a nd of pancreatic islet cell carcinoma.  9/222 
 A.1350  Continuous Glucose Monitor Secondary 
Display  2 A continuous glucose monitor secondary display is identified as a device intended to be used for passive real -time 
monitoring of continuous glucose monitoring dat a. It must not be capable of serving as a stand -alone primary 
display device. The primary display device, which is not a part of the continuous glucose monitor secondary 
display, directly receives the glucose data (for example, it communicates directly wit h transmitter) from the 
continuous glucose meter, which is not a part of the continuous glucose monitor secondary display, and is the 
primary means of viewing the continuous glucose monitor data and alerting the patient to a low or high glucose 
value. A co ntinuous glucose monitor secondary display can be used by caregivers of people with diabetes to 
monitor a person's continuous glucose monitoring data. A device is not a continuous glucose monitor secondary 
display if the data from the primary display devic e 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 we aring the sensor and transmitter).  
A.1358  Insulin therapy adjustment device  2 An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose 
measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in 
optimizing insulin therapy regimens for patients with diabetes mellitus.  
A.1360  Gamma -glutamyl transpeptidase and 
isoenzymes test system  1 A gamma -glutamyl transpeptidase and isoenzymes test system is a device inte nded to measure the activity of the 
enzyme gamma -glutamyl transpeptidase (GGTP) in plasma and serum. Gamma -glutamyl transpeptidase and 
isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and 
primary  and secondary liver tumors.  
A.1365  Glutathione test system  1 A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and 
glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are us ed 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 devi ce 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 histid ine 
in the blood and urine often resulting in mental retardation and disordered speech development.  10/222 
 A.1377  Urinary homocystine (nonquantitative) 
test system  2 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  Hydroxy butyric dehydrogenase test 
system  1 A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha -
hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and 
treatment o f 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) t est system  1 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 treatm ent of various diseases of the adrenal or pituitary glands 
and gonadal disorders.  
A.1390  5-Hydroxyindole acetic acid/serotonin 
test system  1 A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5 -hydroxyindole acetic 
acid/se rotonin in urine. Measurements of 5 -hydroxyindole acetic acid/serotonin are used in the diagnosis and 
treatment of carcinoid tumors of endocrine tissue.  
A.1395  17-Hydroxyprogesterone test system  1 A 17 -hydroxyprogesterone test system is a device intended to measure 17 -hydroxyprogesterone (a steroid) in 
plasma and serum. Measurements of 17 -hydroxyprogesterone are used in the diagnosis and treatment of various 
disorders of the adrenal glands or the ovaries.  
A.1400  Hydroxyproline test system  1 A hydroxyproline 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, a nd 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 me asurements 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.  11/222 
 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 lactate 
dehydrogenase 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 syst em 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/sphing omyelin ratio in amniotic 
fluid test system  2 A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the 
lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat -like 
substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used 
in evaluating fetal maturity.  12/222 
 A.1460  Leucine aminopeptidase test system  1 A leucine aminopeptidase test system is a device intended to measure t he 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 A lipase 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 disorder s (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 s erum, plasma, leukocytes, and urine. Lysozyme measurements are used in the 
diagnosis and treatment of monocytic leukemia and kidney disease.  
A.1495  Magnesium test system  1 A magnesium test system is a device intended to measure magnesium levels in serum a nd 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 dehydrogenase 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 infarcti ons, cancer, and blood disorders such as myelogenous (produced 
in the bone marrow) leukemia.  
A.1505  Mucopolysaccharides (nonquantitative) 
test system  1 A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of 
mucop olysaccharides 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 system  2 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 diag nosis and treatment of methylmalonic aciduria, 
a heritable metabolic disorder which, if untreated, may cause mental retardation.  13/222 
 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 uninary 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 pr esence 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 contr ibuted 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 increase d 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 serum. Ornithine carbamyl transferase measurements are used in the diagnosis and 
treatment of liver diseases, such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), 
cirrhosis, and liver metastases.  
A.1540  Osmolality test system  1 An osmolality test system is a device 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 kid ney 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 o f urine as it relates to numerous renal and metabolic disorders and in the 
monitoring of patients with certain diets.  14/222 
 A.1555  Phenylalanine test system  2 A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in seru m, 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 system  1 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 unt reated, may cause mental retardation.  
A.1565  6-Phosphogluconate dehydrogenase test 
system  1 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 ery throcytes. 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 i ntended 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 cirrhosis, an d 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 treat ment 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 associated with placental insufficiency. Measurements of HPL are also used in 
pregnancies complicated by hypertension, proteinuria, edema, post -maturity, placental insufficiency, or possible 
miscarriage.  
A.1590  Porphobilinogen test system  1 A porphobilinogen test sy stem 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 inherited disea ses associated with disturbed porphyrine 
metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.  15/222 
 A.1595  Porphyrins test system  1 A porphyrins test system is a device intended to measure porphyrins (compounds forme d 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 diseases 
associated w ith disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme 
pathway.  
A.1600  Potassium test system  2 A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements 
obtained by this device are used to monitor electrolyte balance in 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 intended 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 A pregnanetriol test system  is a device intended to measure pregnanetriol (a precursor in the biosynthesis of the 
adrenal hormone cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment 
of congenital adrenal hyperplasia (congenital enlargemen t 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 obt ained 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 measure 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 s ystem  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 genet ic 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 this 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.  16/222 
 A.1645  Urinary protein or albumin 
(nonquantitative) test system  1 A urinary protein or albumin (nonqu antitative) 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 heart diseases or thyroid di sorders, which are characterized by proteinuria or 
albuminuria.  
A.1650  Pyruvate kinase test system  1 A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in 
erythrocytes (red blood cells). Measurements obtained by this device are used in the diagnosis and treatment 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. Measurements obtained by this device are used in the evaluation of 
electrolyte metabolism and in the diagnosis and treatment of acid -base and electrolyte disturbances or anoxia (the 
reduction of oxygen in body tissues).  
A.1660  Quality control material (assayed and 
unassayed)  1,2 (a) Identification: A quality control material (assayed and unassayed) for clinical chemistry is a device intended 
for medical purposes for use in a test syst em 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 includes controls 
(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 am ounts 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 treatment of liver 
disorders such as cirrhosis or acute hepatitis.  17/222 
 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 intend ed 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 
hormones (androg ens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence 
in males and, in females 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 thyrotrophi c hormone, in serum and plasma. Measurements of thyroid stimulating 
hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.  
A.1695  Free thyroxine test system  2 A free thyroxine test system is a device intend ed to measure free (not protein bound) thyroxine (thyroid hormone) 
in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone 
available to the cells and may therefore determine the clinical metabolic statu s 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 t riiodothyronine 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.  18/222 
 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 
disord ers. 
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 t ype 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 amono acid) in serum and urine. 
Measuremen ts obtained by this device are used in the diagnosis and treatment of diseases such as congenital 
tyrosinemia (a disease that can cause liver/kidney disorders) and as an adjunct to the measurement of phenylalanine 
in detecting congenital phenylketonuria (a  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 system  1 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.  19/222 
 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 tre atment 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 A vanilmandelic acid test syst em 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 B12test system is a device intended to measure vitamin B12in serum, plasma, and urine. Measurements 
obtained by this device are used in the diagnosis and treatment of anemias of gastrointes tinal 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 syndrom e (a group 
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 la boratories 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 system  2 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 vitam in 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 t he 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 use  1 A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument 
intended to simultaneously perform multiple chemical procedures using the principles of automated continuous 
flow systems. This device is intended for use in conjunction with certain ma terials to measure a variety of analytes.  20/222 
 A.2160  Discrete photometric chemistry analyzer 
for clinical use  1 A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical 
procedures by performing automatical ly 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. 
Different models of the device incorporate various inst rumentation 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 col or 
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 materials to measure a variety 
of analytes.  
A.2250  Gas liquid chromatography system for 
clinical use  1 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 separate d according 
to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid 
coating.  
A.2260  High pressure liquid chromatography 
system for clinical use  1 A high pressure liquid chromatography system for clinic al 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  2 A high throughput genomic sequence analyzer for clinical use is an analytical instrument s ystem intended to 
generate, measure 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 stora ge mechanisms; data acquisition software; and software to process detected signals.  
A.2270  Thin -layer chromatography system for 
clinical use  1 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.23 00 Colorimeter, photometer, or 
spectrophotometer for clinical use  1 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 condi tions. The device may include a 
monochromator to produce light of a specific wavelength.  21/222 
 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 radiochro matogram) 
for clinical use  1 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 measurement 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  Electroph oresis 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 hemoglobulins on the basis of their net charge in specified buf fered 
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 enzymes in plasma or serum by nonkinetic or 
kinetic measurement of enzyme -catalyzed reactions. This device is used in conjunction with certain materials to 
measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme -related disorders.  
A.2540  Flame emission photometer for clinical 
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. Abnorm al variations in the concentration of these 
substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) 
and are, therefore, 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 de vice includes a signal reader unit, and may also integrate reagent handling, 
hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage 
mechanisms, data acquisition software, and software to process det ected 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 pa rticles in their path). The device 
is used in conjunction with certain materials to measure the concentration of a variety of analytes.  22/222 
 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 that 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 d isorders, 
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 prevent 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 point, 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 flu id 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 velocit y of light in the solution). The 
index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins 
and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain 
conditions.  
A.2850  Atomic absorption spectrophotometer for 
clinical use  1 An atomic absorption spectrophotometer for clinical use is a device intended to identify and measure elements and 
metals (e.g., lead and mercury) in human specimens. The metal elements are identified according to the wavelength 
and intensity of the 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 conditio ns. 
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 separ ating 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 procedures 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 dev ice 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 pre sent in plasma in various disorders.  
A.3030  Acetaminophen tests system  2 An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing 
drug, in serum. Measurements obtained by this device are used in the diag nosis and treatment of acetaminophen 
overdose.  23/222 
 A.3035  Amikacin test system  2 An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum 
and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose 
and in monitoring levels of amikacin to ensure appropriate therapy.  
A.3040  Alcohol test system  2 An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in hu man 
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 intened  to measure alcohol in the human breath. Measurements obtained 
by this device are used in the diagnosis of alcohol intoxication.  
A.3080  Breath nitric oxide test system  2 A breath nitric oxide test system is a device intended to measure fractional nitric o xide 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 assessments of 
asthma . A breath nitric 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 treatment 
of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.  
A.3170  Benzodiazepine test system  2 A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and 
hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, 
oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the 
diagnosis and trea tment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure 
appropriate therapy.  24/222 
 A.3200  Clinical toxicology calibrator  2 A clinical toxicology 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 be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, 
lidoc aine, 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 intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis 
of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. 
True 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 meta bolite 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 o f 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 to measure digitoxin, a cardiovascular drug, in serum and plasma. 
Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in 
monitoring levels of digitoxin 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 treatment of 
diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to  ensure appropriate therapy.  25/222 
 A.3360  Drug metabolizing enzyme genotyping 
system.  2 A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid 
(DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding 
a drug metabolizing enzyme. 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 system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. 
Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in 
monitoring levels of gentamicin to ensure appropriate therapy.  
A.3520  Kanamycin test system  2 A kanamycin test system is a device intended to measure k anamycin, an antibiotic drug, in plasma and serum. 
Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in 
monitoring levels of kanamycin to ensure appropriate therapy.  
A.3550  Lead test system  2 A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained 
by this device are used in the diagnosis and treatment of lead poisoning.  
A.3555  Lidocaine test system  2 A lidocaine test system is a device intende d 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 meproba mate 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.  26/222 
 A.3610  Methamphetamine test system  2 A methamphetamine test system i s a device intended to measure methamphetamine, a central nervous system 
stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and 
treatment of methamphetamine use or overdose.  
A.3620  Methadone test system  2 A methadone test system is a device intended to measure methadone, an addictive narcotic pain -relieving drug, in 
serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use 
or overdose and to determine compliance with regulations in methadone maintenance treatment.  
A.3630  Methaqualone test system  2 A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. 
Measurements obtained by this devi ce 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 gast ric 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 system  2 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 s ystem  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 
pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, 
nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of 
opiate use or overdose and in monitoring the levels of o piate administration to ensure appropriate therapy.  
A.3652  Organophosphate test system  2 An organophosphate test system is a device intended to measure organophosphate metabolites quantitatively in 
human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data 
obtained by this device is 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 t herapy.  
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.  27/222 
 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 pri midone 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 sa licylate 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 quantitatively determine sirolimus concentrations in whole blood. 
Measurements are used as  an aid in management of transplant patients receiving therapy with sirolimus.  
A.3850  Sulfonamide test system  1 A sulfonamide test system is a device intended to measure sulfonamides, any of the antibacterial drugs derived 
from sulfanilamide, in human spe cimens. 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 includedelta -9-
tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtai ned 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 measu re theophylline (a drug used for stimulation of the muscles 
in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by 
this device are used in the diagnosis and treatment of theophylline overdose or in mo nitoring 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 devic e are used in the diagnosis and treatment of tobramycin overdose 
and in monitoring levels of tobramycin to ensure appropriate therapy.  28/222 
 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 doxepin. Measurements obtained by this device are used in the diagnosis and tr eatment 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 c lassification 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 m arkers that are used as adjunctive tests to subclassify tumors, such 
as keratin. (2)Class 2 devices intended for the detection and/or measurement of certain target analytes in order to 
provide prognostic or predictive data that are not directly confirmed b y routine histopathologic internal and 
external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as 
independent diagnostic information to the ordering clinician, and the claims associated with these data a re 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 i n paragraphs (1) or (2) of this section.  29/222 
 B.1865  Cervical intraepithelial neoplasia (CIN) 
test system  2 A cervical intraepithelial neoplasia (CIN) test system is a device used to detect a biomarker associated with CIN 
in human tissues. The device is indica ted 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 resul ts, human papillomavirus (HPV) test results, and 
morphology on hematoxylin and eosin (H&E) stained sections. This device is not intended to detect the presence 
of HPV .  
B.1866  Lynch Syndrome (LS) 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.1870  Early Growth Response 1 (EGR1) gene 
Fluorescence In -situ Hybridization 
(FISH) test system  2 An early growth response 1 (E GR1) gene fluorescence in -situ hybridization (FISH) test system for specimen 
characterization is a device intended to detect the EGR1 probe target on chromosome 5q in bone marrow specimens 
from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The assay results are 
intended to be interpreted only by a qualified pathologist or cytogeneticist. These devices do not include automated 
systems that directly report results without review and interpretation by a qualified pathologist or cytogeneticist. 
These devices also do not include any device intended for use to select patient therapy, predict patient response to 
therapy, or to screen for disease as well as any device with a claim for a particular diagnosis, prognosis, monitoring, 
or risk assessment.  
B.2220  Synthetic cell and tissue culture media 
and components  1 Synthetic cell and tissue culture media and components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts) that are  essential for the survival and development of cell 
lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell 
culture processing applications as described in 876.5885 of this chapter.  
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 d iagnostic 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.  30/222 
 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 pathologis t to review and interpret digital images of surgical pathology slides. The system generates 
digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.  
B.4020  Analyte specific reagents  1,2,3  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 diagn ostic 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. Classification: (1)  Class 1;(2) Class 2 devices 
used in blood banking tests;(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 di agnosis 
offers the opportunity to mitigate the public health impact of the condition (e.g., human immunodeficiency virus 
(HIV/AIDS)or tuberculosis (TB)); or (ii) The analyte is intended as a component in a test intended for use in donor 
screening for condi tions 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).Devices for the following intended use s hould refer to other TFDA regulations including. (a) Devices 
intended to use in the diagnosis of a contagious condition that is highly likely to result in a fatal outcome and 
prompt, accurate diagnosis offers the opportunity to miti - gate the public health .(b) 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  Enzym e 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).  31/222 
 B.5200  Automated cell co unter  2 An automated cell counter is a fully -automated or semi -automated device used to count red blood cells, white 
blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the 
body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also 
calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean 
corpuscular hemoglobin, or the mean corpuscular hemoglobin concent ration). 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, count, or classify immature or abnormal hematopoietic cells of 
the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, 
optical method, o r a flow cytometric method utilizing monoclonal CD (cluster designation) 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 direct ly 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 formation 
for in vitro coagulation studies.  
B.5425  Multipurpose system for in vitro 
coagulation studies  2 A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated 
instrument and its associated reagent s and controls. The system is used to perform a series of coagulation 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 auto mated 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.  32/222 
 B.5680  Automated heparin analyzer  2 An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the 
sample with protamine (a heparin -neutralizing substance) and determining photometrically the onset of air -
activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the 
patient's circulation.  
B.5700  Automated platelet aggregation 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 mea sures 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  Automa ted 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, usuall y 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 use d to count red blood cells, 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 blood to determine whether the patient's total red cell 
volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and 
erythrocytosis (an abnormally high total red cell mass). The packed red ce ll volume is produced by centrifuging a 
given volume of blood.  
B.6550  Occult blood test  2 An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such 
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 conce ntrations of hypotonic saline solutions.  
B.6650  Platelet adhesion test  2 A platelet adhesion test is a device used to determine in vitro platelet function.  33/222 
 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 f or 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 
neoplasms  2 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 hematologically abnormal patients 
having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or 
equivalent professional in conju nction 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 meas urement 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 tre atment of thrombosis. The determination may also be used in the diagnosis of 
thrombophilia (a congenital deficiency of antithrombin III).  
B.7100  Red blood cell enzyme assay  2 Red blood cell enzyme assay is a device used to measure the activity in red bloo d cells of clinically important 
enzymatic reactions and their products, such as pyruvate kinase or 2,3 -diphosphoglycerate. A red blood cell 
enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.  
B.714 0 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 A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the 
production of red blood cells) in serum or urine. This assay provides diagnostic 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 of 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 fibrinolys is. 34/222 
 B.7280  Factor V Leiden DNA mutation detection 
systems  2 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 use d to diagnose specific coagulation defects, to monitor certain types of 
therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a 
coagulation factor deficiency such as hemophilia and the corresp onding 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 i n 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 coagu lation and fibrinolysis 
(the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation 
(nonlocalized clotting in the blood vessels).  
B.7340  Fibrinogen determination 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 dissolut ion of fibrin in a blood clot).  
B.7360  Erythrocytic glucose -6-phosphate 
dehydrogenase assay  2 An erythrocytic glucose -6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme 
glucose -6-phosphate dehydrogenase or of glucose -6-phosphate dehydrogenase isoenzymes. The results of this 
assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug -induced 
hemolytic anemia associated with a glucose -6-phosphate dehydrogenase deficiency. This generi c device includes 
assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet 
kinetics.  
B.7375  Glutathione reductase assay  2 A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase 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  Hemo globin A2 assay  2 A hemoglobin A2assay is a device used to determine the hemoglobin A2content of human blood. The measurement 
of hemoglobin A2is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by 
decreased synthesis of  one or more types of hemoglobin polypeptide chains).  35/222 
 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 diagnos is 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 electrophoretically separates and identifies normal 
and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell 
mass) due to a hemoglobin abnormality.  
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 circu lation or to detect the 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 determination 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 glycosy lated 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 compound of sulfur and hemoglobin) content of human blood as an aid in the 
diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure 
to a poison). This measurement may be made using me thods such as spectroscopy, 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 anticoagu lant heparin in the patient'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 pro tein that 
neutralizes heparin).  36/222 
 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 
occuring in severe infections and polycythemia (increased total red cell mass).  
B.7675  Leukocyte peroxidase test  1 A leukoc yte peroxidase test 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 on the basis  of their peroxidase activity as evidenced by staining. The results of this test 
are used in the differential diagnosis of the leukemias.  
B.7695  Platelet factor 4 radioimmunoassay  2 A platelet factor 4 radioimmunoassay is a device used to measure the leve l of platelet factor 4, a protein released 
during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a 
coagulation disorder, such as myocardial infarction or coronary artery disease.  
B.7720  Prothrombin consumption test  2 A prothrombin 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 
thrombotest  2 The prothrombin -proconvertin test and thrombotest are devices used in the regulation of coumarin ther apy 
(administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and 
pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test 
to detect coagulation disord ers. 
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.  37/222 
 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 co agulation 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 hem atocrit 
measurement  2 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 platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other 
characteristics have been precisely and accurately determined.  
B.8185  Calibrator for red cell and white cell 
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 cha racteristics 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.86 25 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 count 
(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.  38/222 
 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 
components  2 An empty container for the collection 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 bl ood 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 frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize 
hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and 
thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.  
B.9165  Blood establishment computer 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 
posit ive 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 with BECS to augment the 
performance of the BECS or to exp and or modify its indications for use.  
B.9175  Automated blood grouping and antibody 
test system  2 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 antigen s. 
B.9195  Blood mixing devices and blood 
weighing devices  1 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 wa rms 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 t hat 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 use  1 Cell-freezing appara tus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells 
for in vitro diagnostic use.  39/222 
 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 components. 
The remaind er 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 use  1 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 -hematology  2 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 sens itization.  
B.9320  Copper sulfate solution for specific 
gravity determinations  1 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 leve l (12.5 grams per 100 milliliters of blood for women 
and 13.5 grams per 100 milliliters of blood for men).  
B.9400  Stabilized enzyme solution  2 A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of 
red blood 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 proteins 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 concentrate  1 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 are m edia, 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 freezer  1 A blood storage refrigerator 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.  40/222 
 B.9750  Heat -sealing device  1 A heat -sealing device is a device intended for medical purposes tha t 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 conta iner to another.  
B.9900  Cord blood processing system and 
storage container  2 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 which 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 vir uses. Enterovirus cause illnesses such as 
hand, 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 serol ogical 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 b y these viruses. These diseases are transmitted by mosquitos. 
The symptoms of these are similar to influenza including fever, fatigue, cough, and headache. The worst symptom 
is dengue hemorrhagic fever or dengue shock syndrome.  
C.0003  Helicobacter spp. se rological reagents  1 Helicobacter spp. serological reagents  are devces 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) l eading 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.  41/222 
 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, shi ver, 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 dif fusion 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 susceptibility test s ystem 
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 ant imicrobial 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 packaged in 
vials in specified amoun ts 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.164 5 Fully automated  short -term incubation 
cycle antimicrobial susceptibility system  2 A fully automated short -term incubation cycle antimicrobial susceptibility system is a device that incorporates 
concentrations of antimicrobial agents into a system for th e 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 disea ses. 
C.1700  Culture medium for antimicrobial 
susceptibility tests  2 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 action of the enzym e 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 genusStaphylococcus 
and provide epidemiological information on disease caused by  these microorganisms.  42/222 
 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 sssessment system  2 An automated image assessment system for microbial colonies on solid culture media is a system that is intended 
to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret 
their number, and 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 medical 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 cu lture 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 oc curred. 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 medium is a device that consists primarily of liquid or soli d biological materials intended for 
medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional 
requirements). The device consists of a relatively simple basal 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 epidemiological 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 
procedu res 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 promote or inhibit the growth 
of the test organism in the innoc ulated 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.  43/222 
 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 identify certain pathogenic microorganisms. The device contains one or more 
components that suppress the growth of certain microorganisms while either promoting or not affecting the growth 
of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and 
also provides epidemio logical 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 viability of suspected pathogens contained in patient specimens w hile 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 Neis seria 
spp 2 A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological 
materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genusNeisseria, 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 oxidas e 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 mal e'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 unlik ely that cytochrome oxidase -
positive organisms other thanNeisseria gonorrhoeae are present in the urethral discharge of males, the identification 
of cytochrome oxidase with this 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 sup port 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 dilutin g 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.  44/222 
 C.2560  Microbial growth monitor  1 A microbial gr owth monitor is a device intended for medical purposes that measures the concentration of bacteria 
suspended in a liquid medium by measuring changes in light scattering properties, optical density, 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 purposes 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 device  1 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 to 
differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.  
C.2850  Automated zone reader  1 An auto mated 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 suscep tibility tests. The device aids in decisionmaking respecting the treatment 
of disease.  
C.2900  Microbiological specimen collection and 
transport device  1 A microbiological specimen collection and transport device is a specimen collecting chamber intended f or medical 
purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after 
their collection and during their transport from the collecting area to the laboratory. The device may be labeled or 
otherwise repre sented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.  
C.3010  Acinetobacter calcoaceticus serological 
reagents  1 Acinetobacter calcoaceticus serological reagents are devices that consist ofAcinetobacter 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 bacteriumAcinetobacter 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).  45/222 
 C.3020  Adenovirus serological reagents  1 Adenovirus serologi cal 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 id entify adenoviruses directly from clinical specimens. The identification 
aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these 
diseases. Adenovirus infections may cause pharyngitis (inflammation of the th roat), 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 identifyArizona spp. in 
cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by 
bacteria belonging to the genusArizona and provides epidemiological information on diseases caused by these 
microorganisms.Arizona spp. can cause gastroenteritis (food poisoning) and sepsis (blood poisoning).  
C.3040  Aspergillus spp. serological reagents  1 Aspergillus spp. serological reagents are devices that consist of antigens and antisera used in various serological 
tests to identify antib odies toAspergillus spp. in serum. The identification aids in the diagnosis of aspergillosis 
caused by fungi belonging to the genusAspergillus. Aspergillosis is a disease marked by inflammatory 
granulomatous (tumor -like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the 
bones.  
C.3050  Beta-glucan serological assays.  2 Beta-glucan serological assays are devices that consist of antigens or proteases used in serological assays. The 
device is intended for use for the presumpt ive diagnosis of fungal infection. The assay is indicated for use in 
patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device 
can be used as an aid in the diagnosis of deep seated mycoses and fungem ias. 
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 toBlastomyces determatitidis in serum. The identification aids in the diagnosis of 
blastomycosis caused by the fungusBlastomyces 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. serological reagents are devices that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye, used in serolo gical tests to identifyBordetella spp. from cultured isolates or directly from 
clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the 
genusBordetella and provides epidemiological information on these di seases.Bordetella spp. cause whooping 
cough (Bordetella pertussis ) and other similiarly contagious and acute respiratory infections characterized by 
pneumonitis (inflammation of the lungs).  46/222 
 C.3085  Brucella spp. serological reagents  1 Brucella spp. serolo gical reagents are devices that consist of antigens and antisera used for serological 
identification ofBrucella spp. from cultured isolates derived from clinical specimens or to identify antibodies 
toBrucella spp. in serum. Additionally, some of these reag ents consist of antisera conjugated with a fluorescent 
dye (immunofluorescent reagents) used to identifyBrucella spp. directly from clinical specimens or cultured 
isolates derived from clinical specimens. The identification aids in the diagnosis of brucell osis (e.g., undulant fever, 
Malta fever) caused by bacteria belonging to the genusBrucella and provides epidemiological 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 identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. 
The identification aids in the diagnosis of diseas es 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) an d enteritis 
(inflammation of the intestines) in humans.  
C.3120  Chlamydia serological reagents  1 Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify 
antibodies to chlamydia in serum. Additi onally, some of these reagents consist of chlamydia antisera conjugated 
with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from 
clinical specimens. The identification aids in the diagnosis of dis ease caused by bacteria belonging to the 
genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents 
of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chro nic 
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 
identifyCitrobacter spp. from cultured isolates derived from clinical specimens. The identification aids in the 
diagnosis of disease caused by bacteria belonging to the genusCitrobacter and provides epidemiological 
information on diseases caused by these microorganisms.Citrobacter spp. have occasionally been as sociated with 
urinary tract infections.  
C.3130  Clostridium difficile toxin gene 
amplification assay  2 A Clostridium difficile toxin gene amplification assay is a device that consists of reagents for the amplification 
and detection of target sequences in C lostridium difficile toxin genes in fecal specimens from patients suspected 
of having Clostridium difficile infection (CDI). The detection of clostridial toxin genes, in conjunction with other 
laboratory tests, aids in the clinical laboratory diagnosis of CDI caused by Clostridium difficile.  47/222 
 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 toCoccidioides immitis in serum. The identification aids in the diagnosis of 
coccidioidomycosis caused by a fungus belonging to the genusCoccidioides and provides epidemiological 
information on diseases caused by this microorganism. An infection withCoccidioides immitis produces sy mptoms 
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 identifyCorynebacterium spp. from clinical specimens. The identification aids in the diagnosis of disease 
caused by bacteria belonging to the genusCorynebacterium 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 nonpathogen ic 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, som e of these reagents consist of coxsackievirus 
antisera conjugated with a fluorescent dye that are used to identify coxsackievirus from clinical specimens or from 
tissue culture isolates derived from clinical specimens. The identification aids in the diagno sis of coxsackievirus 
infections and provides epidemiological information on diseases caused by these viruses. Coxsackieviruses 
produce a variety of infections, including common colds, meningitis (inflammation of brain and spinal cord 
membranes), herpangin a (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 toCryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identifyCryptococcus neoformans 
directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids 
in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. 
Cryptococcosis infections are found most o ften as chronic meningitis (inflammation of brain membranes) and, if 
not treated, are usually fatal.  48/222 
 C.3175  Cytomegalovirus serological reagents  2 Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological t ests 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 in clusion 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 acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis -
like syndrome.  
C.3200  Echinococcus spp. serological reagents  1 Echinococcus spp. serol ogical reagents are devices that consist ofEchinococcus spp. antigens and antisera used in 
serological tests to identify antibodies toEchinococcus spp. in serum. The identification aids in the diagnosis of 
echinococcosis, caused by parasitic tapeworms belo nging to the genusEchinococcus and provides epidemiological 
information on this disease. Echinococcosis is characterized by the development of cysts in the liver, lung, kidneys, 
and other organs formed by the larva of the infecting organisms.  
C.3205  Echovirus serological reagents  1 Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify 
antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera con jugated 
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 o n diseases caused by these viruses. Echoviruses cause illnesses such as meningitis 
(inflammation of the brain and spinal cord membranes), febrile illnesses (accompanied by fever) with or without 
rash, and the common cold.  
C.3210  Endotoxin assay.  2 An endo toxin assay is a device that uses serological techniques in whole blood. The device is intended for use in 
conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of 
critically ill patients for progre ssion to severe sepsis.  
C.3215  Device to detect and measure non -
microbial analyte(s) for patients with 
suspected sepsis  2 A device to detect and measure non -microbial analyte(s) in human clinical specimens to aid in assessment of 
patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or 
quantitative measurement of one or more non -microbial analytes in human clinical specimens to aid in the 
assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other 
clinical and laboratory findings.  49/222 
 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 toEntamoeba histolytica in serum. Additionally, some of these reagents consist of 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica 
directly from clinical specimens. Th e identification aids in the diagnosis of amebiasis caused by the microscopic 
protozoan parasiteEntamoeba 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, enzyme s, 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 conj unction with other laboratory tests, aids in the clinical laboratory diagnosis of viral 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 v iruses are 
thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw 
in African children and young adults) and postnasal carcinoma (cancer).Classification: (1)Class1 devices for 
diagnosis of infectious m ononucleosis (2)Class 2 devices for diagnosis, prognosis and treatment of Burkitt's 
lymphoma, postnasal carcinoma, and other cancer.  
C.3240  Equine encephalomyelitis virus  
serological reagents  1 Equine encephalomyelitis virus serological reagents are devi ces that consist of antigens and antisera used in 
serological tests to identify antobodies to equine encephalomyelitis virus in serum. The identification aids in the 
diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiologi cal 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  Erysipelo thrix rhusiopathiae serological 
reagents  1 Erysipelothrix rhusiopathiae serological reagents are devices that consist of antigens and antisera used in 
serological tests to identifyErysipelothrix rhusiopathiae from cultured isolates derived from clinical sp ecimens. 
The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusErysipelothrix. 
This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with 
fish, shellfish, or poultry.  50/222 
 C.3255  Escherichia coli serological reagents  1 Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to 
identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these 
reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia 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 genusEscherichia, and provides epidemiological 
information on diseases caused by this microorganism. AlthoughEscherichia coli constitutes the greater part of the 
microorganisms fo und 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 Flavobacteri um spp. serological reagents are devices that consist of antigens and antisera used in serological tests 
to identifyFlavobacteriuim spp. from cultured isolates derived from clinical specimens. The identification aids in 
the diagnosis of disease caused by b acteria belonging to the genusFlavobacterium and provides epidemiological 
information on diseases caused by these microorganisms. Most members of this genus are found in soil and water 
and, under certain conditions, may become pathogenic to humans.Flavobac terium meningosepticum is highly 
virulent for the newborn, in whom it may cause epidemics of septicemia (blood poisoning) and meningitis 
(inflammation of the membranes of the brain) and is usually attributable to contaminated hospital equipment.  
C.3280  Francisella tularensis serological 
reagents  1 Francisella tularensis serological reagents are devices that consist of antigens and antisera used in serological tests 
to identify antibodies toFrancisella tularensis in serum or to identifyFrancisella 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 identifyFrancisella tularensis directly from clinical 
specimens . The identification aids in the diagnosis of tularemia caused byFrancisella tularensis and provides 
epidemiological information on this disease. Tularemia is a desease principally of rodents, but may be transmitted 
to humans through handling of infected a nimals, 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 by 
immunochemical techniques, such as latex agglutination, indirect fluorescent antibody, or radioimmunoassay, 
antibodies toNeisseria gonorrhoeae in sera of asymp tomatic females at low risk of infection. Identification of 
antibodies with this device may indicate past or present infection of the patient withNeisseria gonorrhoeae.  51/222 
 C.3300  Haemophilus spp. serological reagents  1 Haemophilus spp. serological reagents a re devices that consist of antigens and antisera, including antisera 
conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from 
clinical specimens or tissue culture isolates derived from clinical specime ns. The identification aids in the diagnosis 
of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on 
diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumon ia, 
pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and 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 identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes 
simplex virus antisera c onjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes 
simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The 
identification aids in the diagnosis of diseases caused by he rpes simplex viruses and provides epidemiological 
information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin 
and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herp es 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 deivces for other types of HSV identification.  
C.3309  Herpes virus nucl eic acid -based 
cutaneous and mucocutaneous lesion 
panel  2 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. Negative 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 
ragents  1 Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological 
tests to identify antibodies toHistoplasma capsulatum in serum. Additionally, some of these reagents consist 
ofHistoplasma capsulatum antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identifyHistoplasma capsulatum from clinical specimens or cu ltured isolates derived from clinical specimens. The 
identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genusHistoplasma and 
provides epidemiological information on the diseases caused by this fungus. Histoplasmos is usually 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.  52/222 
 C.3328  Influenza virus antigen detection test 
system  2 An influenza virus antige n 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 provide s 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 respirator y 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 anti sera 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 for use in a nucleic acid 
amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Det ection 
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 influe nza 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 mu ltiple sclerosis and Crohn's 
disease patients undergoing natalizumab therapy. These devices are for adjunctive use, in the context of other 
clinical risk factors for the development of progressive multifocal leukoencephalopathy.  
C.3340  Klebsiella spp. ser ological reagents  1 Klebsiella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated 
with a fluorescent dye (immunofluorescent reagents), that are used in serological tests to identifyKlebsiella spp. 
from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused 
by bacteria belonging to the genusKlebsiella and provides epidemiological information on these diseases. These 
organisms can cause serious urin ary tract and pulmonary infections, particularly in hospitalized patients.  53/222 
 C.3350  Leptospira spp. serological reagents  1 Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests to 
identify antibodies toLeptospira spp. in serum or identifyLeptospira spp. from cultured isolates derived from 
clinical specimens. Additionally, some of these antisera are conjugated with a fluorescent dye (immunofluorescent 
reagents) and used to identifyLeptospira spp. directly from clinical specimens. The identification aids in the 
diagnosis of leptospirosis caused by bacteria belonging to the genusLeptospira and provides epidemiological 
information on this disease.Leptospira infections range from mild fever -produc ing 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 
identifyListeria spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents 
consist ofListeria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identifyListeria spp. direc tly from clinical specimens. The identification aids in the diagnosis of listeriosis, a 
disease caused by bacteria belonging to the genusListeria, and provides epidemiological information on diseases 
caused by these microorganisms.Listeria monocytogenes, t he most common human pathogen of this genus, causes 
meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the brain and brain 
membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauter ine infection in 
pregnant women that results in a high mortality rate for infants before or after birth.  
C.3360  Lymphocytic chorimeningitis virus 
serological reagents  1 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 
(inflammation of membranes that envelop the brain) and occasionally a mild pneumonia, but in rare instances may 
produce severe and even fatal illne sses due to complications from cerebral meningitis and pneumonia.  
C.3365  Multiplex nucleic acid assay for 
identification of microorganisms and 
resistance markers from positive blood 
cultures  2 A multiplex nucleic acid assay for identification of microorga nisms and resistance markers from positive blood 
cultures is a qualitative in vitro device intended to simultaneously detect 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. 
Howev er, the device does not replace traditional methods for culture and susceptibility testing.  54/222 
 C.3370  Mycobacterium tuberculosis 
immunofluorescent reagents  1 Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugate d with a 
fluorescent dye used to identifyMycobacterium tuberculosis directly from clinical specimens. The identification 
aids in the diagnosis of tuberculosis and provides epidemiological information on this disease.Mycobacterium 
tuberculosis is the common  causative organism in human tuberculosis, a chronic infectious disease characterized 
by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.  
C.3372  Nucleic acid -based in vitro diagnostic 
devices  for the detection of 
Mycobacterium tuberculosis complex in 
respiratory specimens  2 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 respiratory specimens. These devices 
are non -multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in 
conjunction with clinical and other laboratory 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), bronchia l 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 
specimens  2 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 selecti on of an initial treatment regimen when used in conjunction with clinical findings and other laboratory 
results. These devices do not provide confirmation of antibiotic susceptibility since other mechanisms of resistance 
may exist that may be associated wi th 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 toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly 
from clinical specimens. The identificat ion aids in the diagnosis of disease caused by bacteria belonging to the 
genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms. 
Mycoplasma spp. are associated with inflammatory conditions of the urinary and res piratory tracts, the genitals, 
and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection 
to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.  55/222 
 C.3380  Mumps virus serological reagents  1 Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies 
to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent 
dye (immunofluores cent 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 epidemiological 
information on mumps. Mumps is an acute contagio us 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 serological 
tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. 
antisera conjugated with a fluoresc ent dye (immunofluorescent reagents) which may be used to detect the presence 
ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by 
bacteria belonging to the genusNeisseria, such as epidemic cerebr ospinal meningitis, meningococcal disease, and 
gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device 
does not include products for the detection of gonorrhea in humans by indirect methods, such as d etection 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 a cute gastroenteritis and/or aid in the identification 
of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting of epidemiologically linked patients 
with symptoms of acute gastroenteritis.Classification. Class II  
C.3400  Parainflu enza virus serological reagents  1 Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests 
to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parai nfluenza 
virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza 
viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.  56/222 
 C.3402  Plasmodium species antigen detection 
assays  2 APlasmodium 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. Th ese devices are used for testing specimens from individuals who have signs and 
symptoms consistent with malaria infection. The detection of these antigens aids in the clinical laboratory diagnosis 
of malaria caused by the four malaria species capable of in fecting humans:Plasmodium falciparum ,Plasmodium 
vivax ,Plasmodium ovale , andPlasmodium malariae , and aids in the differential diagnosis ofPlasmodium 
falciparum infections from other less virulentPlasmodium species. The device is intended for use in conj unction 
with other clinical laboratory findings.  
C.3405  Poliovirus serological reagents  1 Poliovirus serological 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 antisera conjugated 
with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from 
tissue culture isolates derived from clinical specimens. The id entification 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 aw ay) 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 
conjugate d with a fluorescent dye (immunofluorescent reagents), derived from the bacteriumProteus 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 
genusRickettsiae 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 identifyPseudomonas spp. from clinical 
specimens or from cultured isolates d erived from clinical specimens. The identification aids in the diagnosis of 
disease caused by bacteria belonging to the genusPseudomonas. Pseudomonas aeruginosa is a major cause of 
hospital -acquired infections, and has been associated with urinary tract in fections, eye infections, burn and wound 
infections, blood poisoning, abscesses, and meningitis (inflammation of brain membranes).Pseudomonas 
pseudomallei causes melioidosis, a chronic pneumonia.  57/222 
 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 identification 
aids in the diagnosis of rabies in patients expo sed 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 (immunofluorescent reagents) 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 syncyti al virus infections and provides 
epidemiological 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 a nd 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 serum. 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 ident ification aids in the diagnosis of diseases caused by virus -like bacteria belonging to the genusRickettsiae 
and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods 
(e.g., ticks and mosquitoes) and prod uce 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 
infor mation on German measles. Newborns infected in the uterus with rubella virus may be born with multiple 
congenital defects (rubella syndrome).  58/222 
 C.3520  Rubeola (measles) virus serological 
reagents  1 Rubeola (measles) virus serological reagents are devices th at 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 infecti ous 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 
identifySalmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these 
reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to 
identifySalmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The 
identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and 
provides epidemiological inf ormation on this disease. Salmonellosis 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 anti sera used in serological tests to 
identify antibodies toSchistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused 
by parasitic flatworms of the genusSchistosoma. Schistosomiasis is characterized by a variety of acute and  chronic 
infections. Acute infection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe 
and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver, lungs, and 
central nervous sys tem. 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 
identifySerratia spp. from cultured isolates. The identification aids in the diagnosis of disease caused by bacteria 
belonging to the genusSerratia and provides epidemiological information on these diseases.Serratia spp. are 
occasi onally 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 identifyShigella spp. from 
cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the 
genusShigella and provides epidemiological information  on this disease. Shigellosis 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 serologic al tests 
to identify antibodies toSporothrix schenckii in serum. The identification aids in the diagnosis of sporothrichosis 
caused by a fungus belonging to the genusSporothrix and provides epidemiological information on this disease. 
Sporothrichosis is a chronic tumorlike infection primarily of the skin.  59/222 
 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 genusStaphylococcus and 
provides epidemiological information on these diseases. Certain s trains ofStaphylococcus 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. e xoenzyme reagents  1 Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme 
in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus 
and provid es epidemiological 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 diseas e. 
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 genusStreptococcus and provides epidemiological 
information on these diseases. P athogenic 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 toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera 
conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical 
specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma 
gondii and provides epidemiological information on this diseas e. 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 bra in and spinal cord.  
C.3820  Treponema pallidum nontreponemal test 
reagents  2 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 th e diagnosis of 
syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information 
on syphilis.  60/222 
 C.3830  Treponema pallidum treponemal test 
reagents  2 Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control 
reagents (standardized reagents with which test results are compared) which are derived from treponemal sources 
and that are used in the fluorescent treponemal antibody absorption test (FTA -ABS), theTrepone ma pallidum 
immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly 
from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by 
bacteria belonging t o the genusTreponema 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 toTrichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by 
parasitic roundworms belonging to the genusTrichinella and provides epidemiological information on trichinosis. 
Trichinosis is caused by ingestio n 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, and female 
urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of 
trichomonias is 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 toTrypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a 
disease caused by parasitic  protozoans belonging to the genusTrypanosoma. 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, inabi lity to eat, tissue wasting, and eventual death. 
Chagas disease, an acute form of trypanosomiasis in children, most seriously 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 epide miological 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 viru ses. Zoster is the response (characterized by a 
rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.  61/222 
 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 identifyVibrio cholerae from cultured isolates derived from clinical specimens. The identification 
aids in the diagnosis of cholera caused by the bacteriumVibrio cho lerae 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 seve re 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/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis 
caused by West Nile virus.  
C.3945  Dengue virus serological reagents  2 Dengue virus serological reagents are devices that consist of antigens and antibodies for the detection of dengue 
virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue hemorrhagic  
fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused 
by dengue virus.  
C.3946  Dengue virus nucleic acid amplification 
test reagents  2 Dengue virus nucleic acid amplification test reagents are de vices that 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 wit h 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 assay  2 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/s usceptibility 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 
fluid  2 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 microbia l-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 i n conjunction with 
clinical signs and symptoms and other clinical and laboratory findings.  62/222 
 C.3980  Respiratory viral panel multiplex nucleic 
acid assay  2 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 res piratory 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 viruses:  
(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 Metapneumovirus;  
(6) Rh inovirus; and  
(7) Adenovirus.  
C.3985  Device to detect and identify 
microorganisms and associated 
resistance marker nucleic acids directly 
in respiratory specimens  2 A device to detect and identify microorganisms and associated resistance marker 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 
symptoms of respirat ory 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 assay  2 A gastrointestinal microorganism multiplex nucleic acid -based assay is a qualitative in vitro diagnostic device 
inten ded 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 well as 
for determining the presence of toxi n 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 used in conjunction with c linical 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.  63/222 
 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 complement, a naturally occurring  serum protein from any warm -
blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the 
diagnosis of disease.  
C.4500  Immunoelectrophoresis   equipment  1 Immunoelectrophoresis equipment for clinical us e 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 basis of their relative mob ilities 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 
measured by means of refl ected light. A beam of light is passed through a solution in which a fluorochrome has 
been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the 
fluorochrome label is detected by a photodetector, which c onverts 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 o f 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 compl exes 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 electrical energy. The amount of e lectrical 
energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is 
called the light -scattering value and is used to measure the concentration of antigen -antibody complexes. This 
generic type of devic e 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.  64/222 
 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 enumeration of FISH signals in interph ase nuclei of 
formalin -fixed, paraffin -embedded human tissue specimens.  
C.4750  Automated indirect immunofluorescence 
microscope and software -assisted system  2 An automated indirect immunofluorescence microscope and software -assisted system is a device tha t 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 sou rce, 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 
software, data storage and transferring mechani sms, 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 device 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 form 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 p rocedure, an electric current causes the protein 
in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a 
rocket -shaped pattern, giving the name to the device. The height of the peak (or the area  under the peak) is 
proportional to the concentration of the protein.  
C.5040  Albumin immunological test 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 immunolog ical 
test system  1 A human allotypic marker immunological test system is a device that consists of the reagents used to identify by 
immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2m, and Km 
allotypes) in serum and o ther body fluids. The identification may be used while studying population genetics.  65/222 
 C.5080  Alpha -1-antichymotrypsin 
immunological test system  2 Analpha -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  Antimitoch ondrial antibody 
immunological test system  2 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 ai d in the 
diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own 
tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation 
of the liver).  
C.5100  Antinuclear antibody immunological test 
system  2 An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues th at react with 
cellular nuclear constituents (molecules present in the nucleus 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 (a liver disease), rheumatoid 
arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic 
sclerosis (chronic hardening and shrinki ng of many body tissues).  
C.5110  Antiparietal antibody immunological test 
system  2 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 cells 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 perni cious anemia), atrophic 
gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the 
body produces antibodies against its own tissues).  
C.5120  Antismooth muscle antibody 
immunological test system  2 An ant ismooth muscle antibody immunological test system is a device that consists of the reagents used to measure 
by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) 
in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune 
connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).  
C.5130  Alpha -1-antitrypsin immunological test 
system  2 Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. 
The measurements aid in the diagnosis of se veral conditions including juvenile and adult cirrhosis of the liver. In 
addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.  66/222 
 C.5150  Bence -Jones proteins immunological test 
system  2 A Bence -Jones proteins immunological te st 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 urine and plasma, and 
have been called Bence -Jones proteins. Measurement of Bence -Jones proteins and determination that they are 
monoclonal aid in the diagnosis o f multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's 
macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia 
(cancer of the blood -forming organs), and lymphoma (cancer of the lympho id tissue).  
C.5160  Beta-globulin immunological test system  1 Abeta -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 
includebeta -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 anin vitro diagnostic device that consists of reagents used to 
quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device 
is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically 
Crohn's disease and u lcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.  
C.5200  Carbonic anhydrase B and C 
immunological test system  1 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 tes t 
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 cerul oplasmin aid in the diagnosis of copper metabolism disorders.  67/222 
 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 p lasma containing protein gamma globulins, predominantly of the IgG class. The device 
may be used 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 mil k begins 1 to 5 days after childbirth.  
C.5240  Complement components immunological 
test system  2 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 tissues. 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 system  2 A complement C1inhibitor (inactivator) immunological test system is a device that consists of the reagents used 
to measur e by immunochemical techniques the complement C1inhibitor (a plasma protein) in serum. Complement 
C1inhibitor occurs normally in plasma and blocks the action of the C1component of complement (a group of serum 
proteins which destroy infectious agents). Meas urement of complement C1inhibitor aids in the diagnosis of 
hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form 
of angioedema associated with lymphoma (lymph node cancer).  
C.5260  Complement C3b inactivator 
immunological test system  2 A complement 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 C3binactivator 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.  68/222 
 C.5320  Properdin fa ctor 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 serum and other body fluids 
is evidence of the involvement of the alternative to the classical pathway of activation of complement (a group of 
plasma proteins which cause  the destruction of cells which are foreign to the body). Measurement of properdin 
factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the 
glomeruli of the kidney), lupus nephritis (kidney disease as sociated with a multisystem autoimmune disease, 
systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis herpetiformis (presence of vesicles 
on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Othe r 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 bloodclotting factor), in platelets (A) or serum (S). Measurements 
of factor XIII, A, S, aid in the diagnosis and treatment of certain bl eeding 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 
amemia.  
C.5350  Fibrinopeptide A immunological test 
system  2 A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques the fibrinopeptide A (a blood -clotting factor) in plasma and other body fluids. 
Measurement of fibrinopeptide A may aid in t he 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, predominantlyalpha - andbeta - globulins, used as a raw material for the production of purealpha - orbeta - 
globulins. Measurement of specificalpha - orbeta - globulins aids in the diagnosis of many diseases, such as Wilson's 
disease (an inherited disease affecting the liver and b rain), Tangier's disease (absence ofalpha - 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 predominantly albumin (a plasma protein). This test aids in the diagnosis of diseases where albumin 
levels may be depressed, e.g., nephrosis (disease of the kidney), proteinuria (protein in the uri ne), 
gastroenteropathy (disease of the stomach and small intestine), rheumatoid arthritis, and viral hepatitis.  69/222 
 C.5380  Free secretory component 
immunological test system  1 A free secretory component immunological test system is a device that consists of t he reagents used to measure by 
immunochemical techniques free secretory 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 Analpha - globulin immunological test system is a device that consists of the reagents used to measure by 
immunochemical techn iques thealpha - globulin (a serum protein) in serum and other body fluids. Measurement 
ofalpha - 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 system  1 Analpha - 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniquesalpha - 1-glycoproteins (a group of plasma proteins found in thealpha - 1 group when 
subjecte d to electrophoresis) in serum and other body fluids. Measurement of specificalpha - 1-glycoproteins may 
aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and 
diabetes.  
C.5425  Alpha -2-glycoprote ins immunological 
test system  1 Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by 
immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha - 2 group 
when s ubjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -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 
system  1 Abeta -2-glycoprotein I immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques thebeta -2-glycoprotein I (a serum protein) in serum and other body fluids. 
Measurement ofbeta -2-glycoprotein I aid s in the diagnosis of an inherited deficiency of this serum protein.  
C.5440  Beta-2-glycoprotein III immunological 
test system  1 Abeta -2-glycoprotein III immunological test system is a device that consists of the reagents used to measure by 
immunochemical  techniques thebeta -2-glycoprotein III (a serum protein) in serum and other body fluids. 
Measurement ofbeta -2-glycoprotein III aids in the diagnosis of an inherited deficiency of this serum protein and 
a variety of other conditions.  
C.5460  Haptoglobin i mmunological 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 s erum. Measurement of haptoglobin 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.  70/222 
 C.5470  Hemoglo bin immunological test system  2 A hemoglobin immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques the different types of free hemoglobin (the oxygen -carrying pigment in red blood 
cells) in blood, urine, plasma, or other body fluids. Measurements of free hemoglobin aid in the diagnosis of 
various hematologic disorders, such as sickle cell anemia, Fanconi's anemia (a rare inherited disease), aplastic 
anemia (bone marrow does not produce enough blood cells), and leukemia (cancer of the blood -forming organs).  
C.5490  Hemopexin immunological test 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 pro tein 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 bo ne marrow to 
compensate for their decreased life span) and sickle cell anemia.  
C.5500  Hypersensitivity pneumonitis 
immunological test system  2 A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measu re 
by immunochemical techniques 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 trigg er an inflammatory reaction (hypersensitivity pneumonitis). Measurement 
of these immunoglobulin G antibodies aids in the diagnosis of hypersensitivity pneumonitis and other allergic 
respiratory disorders.  
C.5510  Immunoglobulins A, G, M, D, and  E 
immunological test system  2 An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used 
to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. 
Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack 
of ability to resist infectious agents.  
C.5520  Immunoglobulin G (Fab fragment 
specific) immunological test system  1 An immunoglobulin G (Fab fragment specifi c) 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 
immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of 
bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and 
bone marrow cells), and lymphoma (tumor of the lymphoid tissues).  
C.5530  Immunoglobulin G (Fc fragment 
specific) immunological test system  1 An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents 
used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G 
(resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement 
of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody -forming abnormalities, e.g., 
gamma heavy chain disease.  71/222 
 C.5540  Immunoglobulin G (Fd fragment 
specific) immunological test system  1 An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the r eagents 
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 system  2 An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used 
to measure by immunoc hemical techniques both kappa and lambda types of light chain portions of 
immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light 
chains are produced by the antibody -forming cells. These free light chai ns, 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), lym phocytic 
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 system  1 A lactic 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 
dehydro genase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of 
mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood -
forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions 
known to cause increased lactic dehydrogenase levels.  
C.5570  Lactoferrin immunological test 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 Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques thealpha - 1-lipoprotein (high -densi ty lipoprotein) in serum and plasma. Measurement 
ofalpha - 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.  72/222 
 C.5600  Low-densit y lipoprotein immunological 
test system  2 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 of low-
density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify 
young persons at risk from cardiovascular diseases.  
C.5620  Alpha -2-macroglobulin immunological 
test system  2 Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-
macroglobulin may aid in the diagnosis of blood -clotting or clot lysis disorders.  
C.5630  Beta-2-microglobulin immunological test 
system  2 Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by 
immunochemical techniquesbeta -2-microglobulin (a protein molecule) in s erum, urine, and other body fluids. 
Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.  
C.5640  Infectious mononucleosis immunological 
test system  2 An infectious mononucleosis immunological test sys tem 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 diagn osis of infectious 
mononucleosis.  
C.5660  Multiple autoantibodies immunological 
test system  2 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 o f 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 system  2 An Aquaporin -4 autoantibody immunological tes t 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 op tica 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 system  2 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 mel litus (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.  73/222 
 C.5700  Whole human plasma or serum 
immunological test system  1 A whole hu man plasma or serum immunological test system is a device that consists of reagents used to measure 
by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid 
in the diagnosis of any disease concerned with  abnormal levels of plasma or serum proteins, e.g., 
agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.  
C.5715  Plasminogen immunological test 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 system  2 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 specifi c 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 system  1 A retinol -binding protein immun ological 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 d isease 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 
systems  2 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 toS. cerevisiae (baker's 
or brewer's yeast) in human serum or plasma. Detection ofS. cerevisiae antibodies may aid in the diagnosis of 
Crohn's disease.  74/222 
 C.5800  Seminal fluid (sperm) immunological 
test system  1 A seminal fluid (sperm) immunological test system is a device that consists of the reagents used fo r legal purposes 
to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged 
instances of rape and other sex -related crimes.  
C.5820  Systemic lupus erythematosus 
immunlogical test system  2 A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to 
measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with 
cellular nuclear double -stranded deoxyribonu cleic 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 a ntibodies).  
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 sy stem.  
C.5870  Thyroid autoantibody immunological test 
system  2 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 t he 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 (enlargement 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 technique s 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 d eficiency anemia.  
C.5890  Inter-alpha trypsin inhibitor 
immunological test system  1 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 dete ction 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 cys tic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for 
stand -alone diagnostic purposes, prenatal diagnostic, pre -implantation, or population screening.  75/222 
 C.5930  Newborn screening test  2 A newborn screening test for  SCID is a prescription device intended to measure T -cell receptor excision circle 
(TREC) DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction based 
test as an aid in screening newborns for SCID. Presumptive positi ve results must be followed up by diagnostic 
confirmatory testing. This test is not intended for use as a diagnostic test, or for screening of SCID -like syndromes, 
such as DiGeorge syndrome or Omenn syndrome. It is also not intended to screen for less acut e SCID syndromes, 
such as leaky SCID or variant SCID.  
C.5940  Autosomal recessive carrier screening 
gene mutation detection system  2 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 
intended for prescription use or over -the-counter use. 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 assessm ent system is for over -the-counter use. This device does not determine the 
person's overall risk of developing a disease.  
C.6010  Tumor -associated antigen immunological 
test system  2 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 re sponse to 
therapy or for the detection of recurrent or residual disease.  
C.6020  Immunomagnetic circulating cancer cell 
selection and enumeration system  2 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 adjunctiv e use in monitoring or predicting cancer disease progression, response to therapy, and for the detection 
of recurrent disease.  
C.6030  AFP-L3% immunological test system.  2 An AFP -L3% immunological test system is an in vitro device that consists of reagents  and an automated instrument 
used to quantitatively measure, by immunochemical techniques, AFP and AFP -L3 subfraction in human serum. 
The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver 
disease  for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging 
studies, and clinical assessment.  76/222 
 C.6040  Gene expression profiling test system for 
breast cancer prognosis  2 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 system  2 An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. 
It yields a single result for the likelihood that an adnexal pelvic mass in a woman , for whom surgery is planned, is 
malignant. The test is for 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.Classification. Class II  
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.60 80 Next generation sequencing (NGS) based 
tumor profiling test  2 A next generation sequencing (NGS) based tumor profiling test is a qualitative in vitro diagnostic test intended for 
NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of 
targeted genes to aid in 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 analyzer  3 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 (Pco2) analyzer  2 An indwelling blood carbon dioxide partial pressure PCO2analyzer is a device that consists of a catheter -tip 
PCO2transducer (e .g., PCO2electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide 
in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.  77/222 
 D.1170  Indwelling blood hydrogen ion 
concentration (pH) analyzer  2 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 
(Po2) analyzer  2 An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter -tip 
PO2transducer (e.g., PO2electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to 
aid in determining the patient's circulatory, ventilatory, and metabolic status.  
D.1400  Carbon dioxide gas analyzer  2 A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas  mixture 
to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques 
such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.  
D.1430  Carbon monoxide gas 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 chromat ography.  
D.1500  Enflurane gas analyzer  2 An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas 
mixture.  
D.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 spectrometry or absorption of infrared or ultraviolet radiation.  
D.1640  Helium gas analyzer  2 A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during 
pulmonary function tes ting. 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 venti latory status. The device may use techniques such as gas chromatography or mass 
spectrometry.  
D.1700  Nitrous oxide gas analyzer  2 A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas 
mixture. The device may use techniques such as infrared absorption or mass spectrometry.  78/222 
 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 patie nt 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.185 0 Monitoring spirometer  2 A monitoring 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 da ta 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 calculator  2 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 
conductors  2 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.  79/222 
 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 use 
Doppler or other ultrasonic principles.  
D.2300  Bourdon gauge flowmeter  1 A bourdon gauge flowmeter is a device intended for medical  purposes that is used in conjunction with respiratory 
equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the 
atmosphere.  
D.2320  Uncompensated thorpe tube 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  Comp ensated thorpe tube flowmeter  1 A compensated thorpe 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 cali brated 
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.  
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 monito r also includes indirect methods of apnea detection such as monitoring 
of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.  
D.2380  Nitric oxide analyzer  2 The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas 
mixtures 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 (re sistance to alternating current) by means of electrodes placed on the 
patient's chest.  80/222 
 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 for 
the resistive element.  
D.2600  Airway pressure monitor  2 An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may 
include a pressure gauge and an alarm.  
D.2610  Gas pressure gauge  1 A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intend ed for medical purposes that is used to 
measure gas pressure in a medical gas delivery system.  
D.2700  Pressure regulator  1 A pressure regulator is a device, often called a pressure -reducing valve, that is intended for medical purposes and 
that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working 
pressure. This device includes mechanical oxygen regulators.  
D.2775  Electrical peripheral nerve stimulator  2 An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical 
current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.  
D.2875  Differential pressure 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 prescription device that applies negative pressure to a patient's neck 
to aid in providing a patent airway during procedures requiring anesthesia.  81/222 
 D.5110  Oropharyngeal airway  1 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.  
D.5115  Device to relieve acute upper airway 
obstruction  2 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 used to inject local anesthetics into a patient and to 
provide continuous regional anesthesia.  
D.5130  Anesthesia conduction filter  2 An anesthesia conduction filter is a microporous filter used while administering to a patient injections 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 anes thesia. 
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 inclu de 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 administrat ion apparatus is to be used in 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 diaph ragm.  
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 An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during 
anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y -piece.  82/222 
 D.5250  Breathing circ uit 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 circ uit. 
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 airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory 
positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive 
airway pressure during inci pient 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 rubber, 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 conj unction 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 for the induction and maintenance of anesthesia during surgical 
procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's 
head.  
D.5430  Gas-scavenging apparatus  2 A ga s-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 exhaus t system.  83/222 
 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 devi ce. 
D.5454  High flow humidified oxygen delivery 
device  2 A high flow humidified oxygen delivery device is a prescription 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 environm ent 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 us ed 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 prev iously 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 
support  3 A membrane lung for long -term pulmonary support is a device used to provide to a patient extracorporeal blood 
oxygenation f or longer than 24 hours.  84/222 
 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 form into gases that are delivered to lower respiratory 
tract of the patient. This device may contain a baffle to generate homogenious downsized aerosol. Heated, 
ultrasonic, gas, venturi, and refillable nebulizers are i ncluded 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 exhal ed gases. It may be used in conjunction 
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 d evice 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 tempe rature 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  Trachea l/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.  85/222 
 D.5770  Tracheal tube fixation device  1 A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually b y 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 th e 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.58 60 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 continuous ventilator (respirator) and accessories is a device intended to mechanically control or assist patient 
breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal 
ventilators are included in this generic type of device. Face masks intended to be used with continuous ventilators 
are included in this classification.  
D.5905  Noncontinuous ventilator (IPPB) and 
accessories  2 A noncontinuous ventilator (intermittent positive pressur e 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.  86/222 
 D.5925  Powered emergency ventilator  2 A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support 
by means of a face mask or a tube inserted into a patient's airway.  
D.5935  External negative pressure 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.59 65 Positive end expiratory pressure 
breathing attachment  2 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 ex halation.  
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 ga s yoke assembly  1 A medical 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, 
Superficial femoral Artery stents ；(2) Class 3 devices intended to be placed other than peripheral arteries. For 
example, Coronary stents,  and Carotid stents.  
E.0002  Cardiovascular excimer laser 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, cont rols ,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 reci pient.  87/222 
 E.0005  Percutaneous transluminal coronary 
angioplasty (PTCA) catheter  2,3 (a) Standard PTCA catheter (1) Identification: A PTCA catheter is a device that operates on the principle of 
hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter 
has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical 
application, constructed from a polymer. The balloon is designed to uniformly expand to a spe cified diameter and 
length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst 
pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the  
balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary 
artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial 
perfusion. A PTCA catheter ma y also be intended for the treatment of acute myocardial infarction; treatment of in -
stent restenosis (ISR) and/or post -deployment stent expansion. (2) Classification: Class 2.  
(b) Cutting/scoring PTCA catheter (1) Identification: A cutting/scoring PTCA ca theter is a balloon -tipped catheter 
with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon 
resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically  
significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA 
catheter may also be indicated for use in complex type C lesions or for the treatment of in -stent restenosis. (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 vascu lar access. 
This device is deployed through the vessel circuit. Endovascular graft systems for aortic aneurysm treatment and 
arteriovenous (A V) dialysis access circuit stenosis treatment are included in this classification.  
E.0008  Percutaneous cardiac abl ation 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 co ntrol 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 monitors 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 p ressure alarm  2 A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes 
the signal, and emits an alarm when the blood pressure falls outside a pre -set upper or lower limit.  
E.1110  Blood pressure com puter  2 A blood 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.  88/222 
 E.1120  Blood pressure cuff  2 A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for 
inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's 
blood pressure.  
E.1130  Noninvasive blood p ressure 
measurement system  2 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 tranducers placed on the surfa ce 
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 to 
introduce 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 probe  2 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 s cattered 
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 procedures  2 This devic e is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is 
indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a 
manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure 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.  89/222 
 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 by 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 or semirigid 
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 t he 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  Corona ry vascular physiologic 
simulation software device  2 A coronary vascular physiologic simulation software device is a prescription 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, myocardial perfusion). A coronary vascular physiologic simulation software 
device is intend ed 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.  90/222 
 E.1435  Single -function preprogrammed 
diagnostic computer  2 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 he art, 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 conjuction with a densitometer or thermodilution 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 inj ection by an angiographic 
or indicator injector and synchronizes the injection with the electrocardiograph signal.  
E.1750  External programmable pacemaker pulse 
generator  2 An external programmable pacemaker pulse generators is a device that can be program med 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 A thermodilution 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 
conditioner  2 A transducer sign al amplifier and conditioner is a device used to provide the excitation energy for the transducer 
and to amplify or condition the signal emitted by the transducer.  
E.2100  Cardiovascular blood 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.  91/222 
 E.2120  Extravascular blood flow probe  2 An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in con junction 
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 fro m an 
analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may 
sound an alarm when the heart rate falls outside preset upper and lower limits.  
E.2310  Apex cardiograph (vibrocardiograph)  2 An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the 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 device, 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 passive 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 the 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 e lectrical 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.  92/222 
 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 e xtravascular 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 impedanc e 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 electrical 
impedance changes in a region of the body such as the arms and legs.  
E.2780  Hydraulic,pneumatic,or photoelectric 
plethysmographs  2 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 ele ctrical 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 System  2 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 th e 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 phono cardiograph 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 blood pressure. These changes 
are transmitted to accessory equipment for processing.  93/222 
 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 provid e an electrical signal 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 connector) 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 receiver  2 A radiofr equency 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 recondition ed by the device into its original format so that it can be displayed.  
E.2920  Telephone electrocardiograph transmitter 
and receiver  2 A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal 
so tha t 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 pace maker 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 thromboemboli through that vessel.  
E.3300  Arterial embolization device  3 A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, 
certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does 
not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embol ization 
devices used in neurovascular applications are also not included in this classification, see K.5950 of this chapter.  
E.3375  Cardiovascular intravascular filter  2 A cardiovascular intravascular filter is an implant that is placed in the inferior ve na cava for the purpose of 
preventing pulmonary thromboemboli (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 provide vascular access. It is commonly 
constructed of materials such as  polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with 
a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself 
is not made of materials of animal origin, including human umbilical cords.  94/222 
 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.  
Classification. Class II  
E.3470  Intracardiac patch or pledget made of 
polypropylene,polyethylene 
terephthalate, or polytetrafluoroethylene  2 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 syst em 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) Classificat ion: (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 sytem 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 electrical 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 ad aptor  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 anal yzer 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.  95/222 
 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 electrode  2,3 (a)Temporary pacemaker electrode --(1)Identification: A temporary pacemaker electrode is a device consisting of 
flexible insulated electrical conductors with one end connected to anexternal 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 with 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)Classificat ion: 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 electrode function tester is a device wh ich 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 devi ces 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 stimulating 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.  96/222 
 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 val ve 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 An endomyocardial 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 
failure  2 An extracorporeal circuit and accessories for long -term re spiratory/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 respiratory failure or acute cardiopulmonary fa ilure, where other available 
treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The 
main devices and accessories of the system include, but are not limited to, the console (hardware), software,  and 
disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, 
and other accessories (e.g., monitors, detectors, sensors, connectors).  
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 m ounting 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 ca rdiopulmonary 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 tubing  2 A cardiopulmonary bypass vascular catheter, cann ula, 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 console  2 A cardiopulmonary bypass heart -lung machine console is a device that consists of a control panel and the electrical 
power and control circuitry for a heart -lung machine. The console is designed to interface with the basi c 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.  97/222 
 E.4250  Cardiopulmonary bypass temperature 
controller  2 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 filter  2 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 bloo dstream 
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 filter  2 A cardiopulmonary bypass cardiotomy suction line blood filter is a  device used as part of a gas exchange 
(oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing 
in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This devic e 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 i nitiating bypass. The device is not used to filter blood.  
E.4290  Cardiopulmonary bypass 
adaptor,stopcock,manifold,or fitting  2 A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, 
surgical, and th erapeutic 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 and measure the flow of gas into the 
oxygenator. The device is calibrated for a specific gas.  
E.4310  Cardiopulmonary bypass coronary 
pressure gauge  2 A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure 
the pressure of the blood perfusing the coronary arter ies. 
E.4320  Cardiopulmonary bypass pulsatile flow 
generator  3 A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to 
create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the 
oxygenator.  
E.4330  Cardiopulmonary bypass on -line blood 
gas monitor  2 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.434 0 Cardiopulmonary bypass level sensing 
monitor and/or control  2 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 be low 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 pump  3 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 pump  2 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.  98/222 
 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 sensor  2 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 sucker  2 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 control  2 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 dil ator 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 prescription device consisting of a delivery system and implant component that is 
used for soft tissue approximation of cardiac ap ical 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 
arterisclerotic 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 c hest 
during the recovery period following surgery.  
E.5150  Embolectomy catheter  2 An embolectomy catheter is a balloon -tipped catheter that is used to remove thromboemboli, 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 in the region of the heart to provide blood flow during cardiac arrest.  99/222 
 E.5210  CPR aid  1, 2 (a)A CPR aid witho ut 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 optimal CPR to the victim. Classification. 
Class I  (b)A CPR Aid device with feedback is a device that provides real -time f eedback 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 accept ed 
CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, 
ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching 
function to aid rescuers in the se quence of steps necessary to perform effective CPR on a victim. Classification. 
Class II  
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 includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy  that 
are used in pediatric defibrillation or in cardiac 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 eith er directly across the heart or on the surface of the body.  
(2)Classification: Class 2.  
(b)High -energy DC -defibrillator --(1)Identification: A high -energy DC -defibrillator is a device that delivers into a 
50 ohm test load an electrical shock of greater tha n 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 dev ice delivers the electrical shock through 
paddles placed either directly across the heart or on the surface of the body.  
(2)Classification: Class 3.  100/222 
 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 electrode, adapter, 
and hardware key for pediatric use). An AED system analyzes the patient's electrocar diogram, 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 tachyca rdia. 
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 system  2 A steerable cardiac ablation catheter remote control system is a prescription 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 thermal regulation device is a prescription device used to apply a specified temperature t o 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 exclude d 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 for the diagnosis and treatment planning of 
orthodontic patients  101/222 
 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 el ectrode 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 fluorescence measurement 
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 th e tube, to prevent the misfocusing of the x -rays by absorbing divergent radiation, 
and to prevent leakage of radiation.  102/222 
 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 periodontal pocket probing depths, 
detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal pockets, 
as an adjun ct 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 dete cts and records sounds made by the temporomandibular joint.  
Classification: Class 1.  
(2)Dental sonography device for interpretation and diagnosis is an electrically powered device, intended to 
interpret temporomandibular joint sounds for the diagnosis of t emporomandibular joint disorders and associated 
orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint 
during jaw movement. The device interprets these sounds to generate meaningful output, either direc tly 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 a nd records anatomical distances and angles in three dimensional space, to 
determine the relative position of 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 tra cking device for interpretation of mandibular jaw positions for the diagnosis --(1)Identification. A jaw 
tracking device for interpretation of mandibular jaw positions relative to the maxilla for the diagnosis of 
temporomandibular joint disorders and assoc iated orofacial pain is a nonpowered or electrically powered device 
that measures and records anatomical distances and angles to determine the relative position of the mandible in 
three dimensional space, with respect to the location and position of the ma xilla, while at rest and during jaw 
movement. The device records, displays, and stores information about jaw position. The device interprets jaw 
position to generate meaningful output, either directly or by connection to a personal computer. The device may  
be a part of a system of devices, contributing jaw position information to be considered with data from other 
diagnostic components. (2)Classification: Class 2.  103/222 
 F.3060  Gold based alloys and precious metal 
alloys for clinical use  2 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 
powd er in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in 
teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to 
be combined with each other to f orm 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 premeasu red amount of alloy 
pellets.  
F.3100  Dental amalgamator  1 A dental amalgamator is a device, usually AC -powered, intended to mix, by shaking, amalgam capsules containing 
mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is 
intended for filling dental caries.  
F.3110  Dental amalgam capsule  1 A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form 
dental amalgam.  
F.3130  Preformed anchor  1 A preformed anchor is a device made of 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 m outh.  
F.3140  Resin applicator  1 A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of 
tooth shade material.  
F.3165  Precision attachment  1 A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended for use in prosthetic 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.320 0 Resin tooth bonding agent  2 A resin tooth bonding agent is a device material, such as methylmethacrylate, 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 p lacement of artificial teeth into a denture base.  104/222 
 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 m etals, 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, such as amalgam, to protect the pulp of a tooth.  
F.3260  Cavity varnish  2 Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion 
of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, 
into the dentinal tissue.  
F.3275  Dental cement  1,2 Dental cement is a device intended to serve as a temporary tooth filling or as a base cement to affix a temporary 
tooth 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: T he main component is Dental 
cement other than zinc oxide -eugenol.  
F.3285  Preformed clasp  1 A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 
75 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 in the patient's mouth by fastening the appliance to an 
adjacent tooth.  
F.3300  Hydrophilic resin coating for dentures  2 A hydrop hilic 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  Coatin g material for resin fillings  2 A coating material for resin fillings is a device intended to be applied to the surface of a restorative 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 crow n (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 deciduo us (baby) tooth until the adult tooth erupts.  
F.3350  Gold or stainless steel cusp  1 A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group or stainless steel intended to provide a 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.  105/222 
 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) befo re permanent restoration of a tooth.  
F.3400  Karaya and sodium borate with or 
without acacia denture adhesive  1,3 A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium 
borate with or without acacia int ended to be applied to the base of a denture before the denture is inserted into 
patient's mouth to improve denture retention and comfort.  
(1)Classification: Class 1 the device contains less than 12 percent by weight of sodium borate. ；(2)Class 3 the 
device  contains 12 percent or more by weight of sodium borate.  
F.3410  Ethylene oxide homopolymer and/or 
carboxymethyl -cellulose sodium denture 
adhesive  1 An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing 
ethylene 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 
adhesive  3 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 adhesive  1 Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of et hylene 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 adhesive  3 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 
adhesive  1 A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium -sodium double salt denture 
adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid 
calcium -sodium double salt intended to be applied to the base of a denture before the denture is inserted in a 
patient's mouth to improve denture retention and comfo rt. 
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 adhe sive 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 comfo rt. 
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.  106/222 
 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 int ended 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 dentur e 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 to replace 
a worn denture lining and may be available for purchase over the counter.  
F.3570  OTC denture repair kit  2 An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and 
liquid glues, that is intended to be applied pe rmanently 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 g reater 
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 materials 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 comp osed 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 t he 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 is a premanufactured prosthetic component directly connected to the 
endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.  
F.3640  Endosseous implant  3 An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that is intended to 
be 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 tissue covering the bone) and supporting bony structures . The device is intended to provide 
support for prostheses, such as dentures.  107/222 
 F.3660  Impression material  2 Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a 
preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended 
to provide models 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 f or use in a two -step dental mold fabricating process. The 
device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for 
use in cases in which a preformed impression tray is not suitable, such as the fabr ication of crowns, bridges, or full 
dentures. A preliminary plaster or stone model of the patient's teeth and gums is made. The resin impression tray 
material is applied to this preliminary study model to form a custom tray. This tray is then filled with i mpression 
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 material  2 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 contains the sockets in which teeth are rooted) or i ntended 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 d evice 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, such as nickel, chromium, or cobalt, 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 retent ive 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 cr own, 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, such as 
polymethylmethacrylate, intended to cement an orthodonti c 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 methylmethacrylate, 
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.  108/222 
 F.3765  Pit and fissure sealant and conditioner  2 A pit and fissure sealant and conditioner is a device composed of resin, such as p olymethylmethacrylate, 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 r esin is a device composed of material, such as methylmethacrylate, intended for use during 
endodontic therapy to fill the root canal of a tooth.  
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 tropical trees intended to fill the root canal of a tooth. 
The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.  
F.3890  Endodontic stabilizing splint  2 An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through 
the root canal into the upper or lower jaw bone to stabilize a tooth.  
F.3900  Posterior artificial tooth with  a metal 
insert  1 A posterior artificial 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 teeth by a bridge and is intended to provide both an improvement in appearance 
and functional occlusion (bite).  
F.3910  Backing and facing for an artificial 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 tooth 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 repair  2,3 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.  109/222 
 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 mandibular 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 i n the temporomandibular joint to augment 
a glenoid fossa or to provide an articulation surface for th e 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 inte rface 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 en dosseous 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, countertorque devices, placement and removal tools, laboratory pieces 
used for fabrication of dental prosthetics, and trial abutment s. 
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, ha nd-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 s yringe.  110/222 
 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 oral 
surgery 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, su rgical 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 punc h, endodontic pulp canal reamer, crown 
remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical 
osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for  calculus 
removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue 
scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic 
bracket aligner, o rthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps 
for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic 
or endodontic irrigating syringe, and  restorative or impression material syringe.  
F.4600  Intraoral ligature and wire 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 intende d 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.  111/222 
 F.4770  Temporary mandibular condyle 
reconstruction  plate  2 A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and 
provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in 
patients who have under gone 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) thera py 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 b one 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. An electrical current passes through the tip of the electrode into the 
tissue and, depending upon the operating mode selected, cuts t hrough soft tissue or coagulates 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, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed 
orthodontic space maintainer, orthodontic expansion screw retainer, orthodont ic spring, orthodontic tube, and 
orthodontic wire.  
F.5470  Orthodontic plastic bracket  2 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.  
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 intended to wrap around the pati ent'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 the position of the 
teeth.  
F.5560  Electrical salivary stimulatory system  2 An electrical salivary stimulatory system is a prescription intraoral device that is intended to electrically stimulate 
a relative increase in saliva production.  112/222 
 F.5570  Intraoral devices for snoring and 
intraoral devices for snoring and 
obstructive sleep apnea  2 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn 
during sleep to reduce the incidence of snoring and to treat obstructive sleep apn ea. 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 as gold, and 
to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by 
a handpiece. The device includes the 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 th e 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 airb rush 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 o f 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.  113/222 
 F.6300  Rubber dam and accessories  1 A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in th e 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 includes the rubber dam, 
rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include 
devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices 
are classified as condoms in 884.5 300 of this chapter.  
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 b leaching 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 ma ke 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 base for other dental devices, such as a dental handpiece, a dental operat ing 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 dentistr y 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 sterilizer is a device intended to sterilize endodontic and other denta l 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 needle to the syringe body and activating the carpule by partially 
insertin g the plunger on the syringe, the device is used to administer an injection to the patient.  
F.6870  Disposable fluoride tray  1 A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use 
the tray, the patient bites down on the tray which has been filled with a fluoride solution.  114/222 
 F.6880  Preformed impression tray  1 A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to 
make an impression of a p atient'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 -classific ation 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 curr ents, etc.) to stimulate auditory nerve.  
G.1050  Audiometer  1,2 An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones 
and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible 
otologic disorders.Classification: (1) Class I ;(2) Class II: otoacoustic emission device.  
G.1070  Short increment sensitivity index (SISI) 
adapter  1 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 teste r 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 tympanic membrane to evaluate the functional condition 
of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to 
stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic 
reflex threshold from contractions of the st apedial muscle, to monitor healing of tympanic membrane grafts or 
stapedectomies, or to monitor followup treatment for inflammation of the middle ear.  
G.1100  Earphone cushion for audiometric testing  1 An earphone cushion for audiometric testing is a devic e 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 testing  2 An electro nic 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 th e non -test ear's sensing of test tones and signals being generated for the ear 
being tested.  115/222 
 G.1325  Electroglottograph  2 An electroglottograph is an AC -powered device that employs a pair of electrodes that are placed in contact with 
the skin on both sides  of the larynx and held in place by a collar. It is intended to measure the electrical impedance 
of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral 
treatment of voice disorders, and aid re search 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 stim ulus resulting in taste sensation. It is 
used for assessing the sense of taste.  
G.1600  Olfactory test device  1 An olfactory test device is used to determine whether an olfactory loss is present. The device 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 that 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 involuntary 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 d evice includes the air -conduction hearing aid and the bone -conduction hearing aid, but excludes 
the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker 
(874.3400).  
G.3310  Hearing aid calibrator and an alysis 
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 hearin g 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 distoration analyzer, 
a chart record er, and a hearing aid test box. 
G.3315  Tympanic membrane contact hearing aid  2 A tympanic membrane contact hearing aid is a prescription 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.  116/222 
 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 communicating 
simultaneously with one or more listeners having heari ng impairment. The device is used with an associated 
transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either 
earphones or earmolds. The generic type of device includes three types of applications: h ardwire 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 mas k 
ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an 
aid in hearing external noises and speech.  
G.3430  Middle ear mold  2 A middle ear mold is a preformed device that is intended to be imp lanted 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 mad e of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, 
polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a 
combination of these materials.  
G.3495  Total ossicul ar replacement  prosthesis  2 A total ossicular replacement prosthesis is a device intended to be implanted for the total functional 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 composite, porous polyethylene, or from a combination of these materials.  
G.3540  Prosthesis modification instrument for 
ossicular re placement surgery  1 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 cri mper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; 
and ossicular finger vise.  117/222 
 G.3620  Ear, nose, and throat synthetic polymer 
material  2 Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a 
space -occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in 
augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the 
suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh 
or foil and porous polyethylene.  
G.3695  Mandibular implant facial prosthesis  2 A mandibular implant facial prosthesi s 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 elas tomer, 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 devi ce 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 symptons 
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.  118/222 
 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 nasal 
airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is 
constructed from one or more layers of material up on 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 a cts by pushing the nostrils open or by 
gently pressing on the columella.  
G.3930  Tympanostomy tube with semipermeable 
membrane  2 A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or 
drainage of the middl e 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 system  2 A transcutaneous air conduction hearing aid system is a wearable sound -amplifying device intended to compensate 
for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached 
to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the 
outer ear canal.  
G.4100  Epistaxis balloon  1 An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by 
exerting pressure against the sphenopalatine artery.  
G.4140  Ear, nose, and throat bur  1 An ear, nose, and throat bur is  a device consisting of an interchangeable drill bit that is intended for use in an ear, 
nose, and throat electric or pneumatic surgical drill (874.4250) 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 prescription  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 elec tric or 
pneumatic surgical drill  2 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 (874.4140), for the  controlled 
incision or removal of bone in the ear, nose, and throat area.  119/222 
 G.4350  Ear, nose, and throat fiberoptic light 
source and carrier  1 An ear, nose, and throat fiberoptic light source and carrier is an AC -powered device that generates and transmits  
light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat 
endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, 
esophagoscope, laryngoscop e, mediastinoscope, laryngeal -bronchial telescope, and nasopharyngoscope.  
G.4420  Ear, nose, and throat manual surgical 
instrument  1 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 includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); 
tracheal dilator; tracheal hook; laryng eal 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 suct ion tube; tonsil suturing hook; antom reforator; 
ethmoid curette; frontal sinus -rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; 
sinus irrigator; sinus trephine; ear 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 clamp; 
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 
laryngology  2 The argon laser device for use in otology, rhinology, and laryngology is an electro -optical device which produces 
coherent, electrom agnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the 
device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In 
rhinology and laryngology, the device is used t o coagulate and vaporize soft and fibrous tissues, but not including 
osseous tissues.  
G.4500  Ear, nose, and throat microsurgical 
carbon dioxide laser  2 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 
accessories  2 A bronchosco pe (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory 
devices which attach to the bronchoscope 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 type of device includes the rigid ventilating bronchoscope, 
rigid nonventilating bronchoscope, nonrigid bronchoscop e, 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.  120/222 
 G.4710  Esophagoscope (flexible or rigid) and 
accessories  2 An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of 
accessory devices which attach to the esophagoscope  and is intended to examine or treat esophageal malfunction 
symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the 
device extends from the area of the 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 cur ette, 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 devi ce 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 
determ ine 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 flexi ble 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.4750  Laryngostroboscope  1 A laryngostroboscope is a dev ice 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 sig nals from the glottic area may or may not contact the 
patient.  
G.4760  Nasopharyngoscope (flexible or rigid) 
and accessories  2 A nasopharyngoscope (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 a nd flexible plastic. This generic type of device includes the antroscope, 
nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible 
foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible bio spy 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 a dhesions 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.  121/222 
 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 substance  1,2 (a)Identification: An e ar, 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.(b)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 combin ation 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 
treatme nt unit  1 An ear, nose, and throat examination and treatment unit is an AC -powered device intended to support a patient 
during an otologic examination while providing specialized features for examination and treatment. The unit 
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 s ituation 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 si tuation to grasp and remove 
foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. This generic type of device 
includes a plastic instrument with serrated ends that is inserted into the airway in a blind manner to grasp an d 
extract foreign objects, and a stainless steel forceps with spoon ends that is inserted under tactile guidance to grasp 
and extract foreign objects from the airway.  
G.5550  Powered nasal irrigator  1 A powered nasal irrigator is an AC -powered device intended to wash the nasal cavity by means of a pressure -
controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and 
nozzle.  
G.5800  External nasal splint  1 An external nasal splint is a rigid or parti ally 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.  122/222 
 H.0002  Dialyzer reprocessing system  2 An haemodialysis 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 System  3 An urological extracorporeal shock wave therapy system is a device that can treat urology -related diseases by 
generating shock waves. This device can be used only by health professionals.  
H.1075  Gastroenterology -urology biopsy 
instrument  1,2 (a) A gastroent erology -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 i nstrument, gastro -urology biopsy needle and needle set, and 
nonelectric biopsy forceps. This section does not apply to biopsy instruments that have been used in other medical 
specialty areas or covered by biopsy instruments of relevant classification categ ories.(b) 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 system  2 An ingestible telemetric gastrointestinal capsule imaging system i s used for visualization of the small bowel 
mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of 
the small bowel with a wireless camera contained in a capsule. This device includes an ingestible c apsule 
(containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data 
storage device, computer software to process the images, and accessories.  
H.1330  Colon Capsule Imaging System  2 A prescription, 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 incomp lete 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.  123/222 
 H.1500  Endoscope and accessories  1,2 (a) An endoscope  and accessories is a device used to provide access, illumination, and allow observation or 
manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible 
instruments that are inserted into body spaces and may in clude 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 inc lude cleaning accessories for 
endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for 
endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, 
cystourethroscop es, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators 
for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, 
nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, end omagnetic retrievers, cytology brushes 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 in other medical specialty areas or 
covered by endoscopes of relevant classification categories.  
(b) Classification: (1) Class 2. (2) Class 1 for the photographic accessories for endoscope, miscellaneous bulb 
adapter for endoscope, binocular attachment for endoscope, eyepiece attachment f or 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 battery 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 elec trical activity of the muscles associated with urination. The device system may 
include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable 
a urethral pressure profile to be obtained, and special cathet ers for urethral profilometry and electrodes for 
electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the 
cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that use s 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.  124/222 
 H.1735  Electrogastrography system  2 An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the 
diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, 
strip chart, cables, analytical software, and other accessories.  
H.1800  Urine flow or volume measuring system  1 A urine flow or volu me 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 electrical signal conditioning and display equipment. This generic type of device includes the electrical 
urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectr ic urine flow rate meas uring 
device, and uroflowmeter.  
H.2050  Prostate lesion documentation system  2 A prostate lesion documentation system is a prescription device intended for use in producing an image of the 
prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. 
The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights 
regional differences in intraprostatic tissue elasticity or stiffness. T he 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 th e 
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 diag nosed 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 duri ng lower 
abdominal or pelvic surgery.  
H.4270  Colostomy rod  2 A colostomy rod is a device used 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.  125/222 
 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 plate, electric biopsy 
forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, 
self-opening rigid snare, f lexible 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 debris and fluids during gastroenterological and 
urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator 
system, manually powered bladder evacuator, and the AC -powered vacuum pump. Classification: (1) Class 2 
devices for the gastroenterology -urology evacuator when other than manually powered. ；(2) Class 1 devices for 
the gastroenterology -urology evacuator when m anually 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 ligature or 
band placed around the hemorrhoid.  
H.4480  Electrohydraulic lithotriptor  2 An electrohydraulic lithotriptor is an AC -powered device used to fragment urinary bladder stones. It consists of a 
high 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 drainag e 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 include a protective cap to fit over the 
metal threads.  
H.4620  Ureteral stent  2 A ureteral stent is a tube -like implanted device that is inserted into the urete r to provide ureteral rigidity and allow 
the passage of urine. The device may have finger -like protrusions or hooked ends to keep the tube in place. It is 
used in the treatment of ureteral injuries and ureteral obstruction.  126/222 
 H.4650  Water jet renal stone di slodger system  1 A water jet renal stone dislodger system is a device used to dislodge stones from renal 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 includes the metal basket and the flexible ureteral 
stone dislodger.  
H.4730  Manual gastroenterolgoy -urology 
surgical instrument and accessories  1 A manual gastro enterology -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 instru ments 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 belts used to support a patient 
in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position 
manu ally 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 cath eter and accessories  2 A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the 
biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic 
type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened 
to the patient with a strap.  
H.5015  Pancreatic drainage stent  2 A pancreatic drainage stent is a prescription 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.  127/222 
 H.5020  External penile rigidity devices  2 External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual 
intercourse. External penile rigidity devices include vacuum pumps, constriction rings, an d penile splints which 
are mechanical, powered, or pneumatic devices.  
H.5025  Vibrator for climax control of premature 
ejaculation  2 A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It 
is desig ned 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 periodically 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 to and from the 
urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter 
punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar. Classification: (1)C lass 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 includes radiopaque urological catheters, 
ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, u pper 
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, ur eteral 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 voiding 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 used 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.  128/222 
 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  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 tubing 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 device may use electrical power to heat the water. The 
device does not include the enema kit. Classification: (1)Class 2 devices intended for colon cleansing when 
medically indicated, such as before radiological or endoscopic  examinations. ；(2)Class 3 devices intended for 
other uses, including colon cleansing routinely for general well being.  
H.5250  Urine collector and accessories  1,2 A urine collector and accessories is a device intended to collect urine. The device and acces sories 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 c onnected to an indwelling catheter, which includes the urinary 
drainage collection kit and the closed urine drainage system and drainage bag; and  
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes t he 
corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, 
and the paste -on device for incontinence. 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 incontinence that consists of a 
receiver implanted in the abdomen with electrodes for pulsed -stimulation that are implanted either in the bladder 
wall or in the pelvic floor, and a battery -powered transmitter outside the body.  
H.5280  Implanted mechanical/hydraulic urinary 
continence device  3 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 tota lly implanted device may consist 
of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and 
valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. 
The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.  129/222 
 H.5310  Nonimplanted, peripheral electrical 
continence device  2 A nonimplanted, peripheral electrical continence device is a device that consists o f an electrode 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 ur inary 
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 pessar y may be removed by the user. This classification excludes an AC -powered 
nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (L.5940).  
H.5365  Esophageal dilator  2 An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with 
mercury or a metal olive -shaped weight that slides on a guide, such as a string or wire and is used to dilate a 
stricture of the esophagus. This generic type of device includes esoph ageal or gastrointestinal bougies and the 
esophageal dilator (metal olive).  
H.5450  Rectal dilator  1 A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may 
interfere with its function or the passa ge 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 
urethr al 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  
system  2 An implantable transprostatic tissue retractor system is a prescription use 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 hy perplasia in men.  130/222 
 H.5540  Blood access device and accessories  1,2 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 artifici al kidney system for 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 bo th the 
implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device 
and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in 
appropriate blood vesse ls, may come through the skin, and 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 l umen 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 additional functionality to the device. (2)The noni mplanted blood access device 
consists 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 stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp 
plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents). 
Classification:(1)Class 2 (special controls) for the implanted blood access device. ;(2)Class 2 for the nonimplanted 
blood access device. ;(3) Class 2 for accessories for both the implanted and the nonimplanted blood access devices 
not listed in paragraph.(4)of this section.;(4)Class 1 for the cannula clamp, disconnec t forceps, crimp plier, tube 
plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device.  
H.5600  Sorbent regenerated dialysate delivery 
system for hemodialysis  2 A sorbent regenerated dialysate delivery syste m 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 
(876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte bala nce, 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.  131/222 
 H.5630  Peritoneal dialysis system and 
accessories  2 (1)A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the 
treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an 
administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. 
After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesi - rable 
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 time, and draining of the peritoneal cavity or manual controls may be used. This generic 
device includes the semiautomatic and the automatic perito - neal 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 peritioneal catheter, intended to remain 
in the peritoneal ca vity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and 
trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the 
abdominal wall between treatments.(3)The  disposable administration set for peritoneal dialysis consists of tubing, 
an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove 
contaminating particles.(4)The source of dialysate may be ster ile prepackaged dialysate (for semiautomatic 
peritoneal dialysate delivery systems or "cycler systems") or dialysate prepared from dialysate concentrate and 
sterile purified water (for automatic peritoneal dialysate delivery systems or "reverse osmosis" sy stems). 
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 int ended 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.  132/222 
 H.5820  Hemodialysis system and accessories  1,2 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 extracorporeal 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 further 
tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by 
a semipermeable membrane. While the blood is in the blood compartment, undesirable s ubstances 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 extrac orporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or 
bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for 
hemodialysis (876.5540) to the blood compartment of th e 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) 
(876.5830) or dialyzers  of high permeability (876.5860).  
 
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, 
flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the d ialyzer. 
The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms 
to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated 
dialysate delivery s ystem for hemodialysis (876.5600), the dialysate delivery system of the peritoneal dialysis 
system and accessories (876.5630), or the controlled dialysate delivery system of the high permeability 
hemodialysis system 876.5860).  
(4) Remote accessories to the  hemodialysis system include the unpowered dialysis chair without a scale, the 
powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop 
tray. 133/222 
 H.5830  (kiil type)(Hemodialyzer with disposable 
insert (kiil type)  2 Classification: (1)Class 2 for hemodialysis systems and all accessories directly associated with the extracorporeal 
blood system and the dialysate delivery system. ；(2)Class 1 for other accessories of the hemodialysis system 
remote from t he extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis 
chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties.  
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, hemofiltration, hemoconcentration, and hem odiafiltration. Using a hemodialyzer with a 
semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional 
hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from 
the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or 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 monit ors 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 devic es: 
 
(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, and is used with e ither 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 hemodialysis sys tem and accessories (876.5820), 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, urea,  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, and blood recirculation monitors).  134/222 
 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 (876.5820) and a container filled with adsorbent material 
that removes a  wide range 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 d evice 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 accessories  2 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 transplant ed 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.  
H.5885  Tissue culture media for human ex vivo 
tissue and cell culture processing 
applications  2 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) that are essential for the ex vivo development, survival, and mai ntenance 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 w ith 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.5930  Rectal control system  2 A rectal control  system is a prescription 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.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 following an 
ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the 
ureter on the surfa ce of the body). This generic type of device and its accessories includes the ostomy pouch, 
ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, 
urine collecting ureterostomy bag, ostomy drainage ba g with adhesive, stomal bag, ostomy protector, and the 
ostomy size selector, but excludes ostomy pouches which incorporate a rsenic -containing compounds.  135/222 
 H.5955  Peritoneo -venous shunt  2 A peritoneo -venous shunt is an implanted device that consists of a cat heter 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 intr actable 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, withdr awing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may 
incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the 
hemostatic bag, irrigation and aspiration cathet er (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, 
gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or 
intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogas tric tube, single lumen tube with mercury 
weight balloon for intestinal intubation or decompression, and gastro -urological irrigation tray (for gastrological 
use).  
Classification: (1)Class 2 ；(2)Class 1 for the dissolvable nasogastric feed tube guide for th e 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 sys tem. 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 fragmented by 
the focused shock waves, the fragments pass out of the body  with the patient's urine.  
H.9999  Others(Gastroenterology and Urology 
Devices)  1,2,3  The products excluded from the above -classification are adopted in this classification and specified by the central 
competent health authority.  
I.0001  High density  electrical current 
subcutaneous wrinkle reduction device  2 A device with high density electrical current for subcutaneous wrinkle reduction is a device applying an electrical 
current to electrodes on a patient's skin up to subdermal or muscle layers for re ducing 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.  136/222 
 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 ab lation. 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 fr om the environments. Surgical gowns are not included in this identification. Classification: Class 2.  
I.0007  Hyaluronic Acid Implants  3 Hyaluronic acid implants are hyaluronic acid substances used to modify or filled into surface defects on the face 
or other body positions.  
I.0008  Transcutaneous skin stimulator  2 A transcutaneous skin stimulator applies energy (e.g., electrical current, optical energy or ultrasound energy) on a 
patient's skin up to dermal or subdermal layers to modify skin appearance (e.g., skin tightening, toning, lifting or 
reducing wrinkles) or to stimulate collagen or cell production.  
I.0009  High Intensity Focused Ultrasound 
(HIFU) Ablation System  3 An high intensity focused ultrasound (HIFU) ablation system is intended to use HIF U to ablate soft tissue or 
specific cell tissue. The system needs to be used with medical imaging systems (e.g., MR imaging systems) 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.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 quantitati ve or diagnostic information.  
I.4371  Irrigating wound retractor device  2 An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical 
incision, to provide access to the surgical wound, to protect a nd irrigate the surgical wound, and to serve as a 
conduit for removal of fluid from the surgical wound.  
I.4685  Extracorporeal shock wave device  2 An extracorporeal shock wave device for treatment of chronic wounds is a prescription 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.  137/222 
 I.4815  Magnetic surgical instrument system  2 A magnetic surgical instrument system is a prescription devi ce used in laparoscopic surgical procedures consisting 
of several components, such as surgical instruments, and a magnetic controller. The magnetic controller is provided 
separately from the surgical instrument and is used outside the patient. The external  magnetic controller is 
magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, 
or manipulate soft tissue and organs.  
I.1800  Speculum and accessories  1 A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or 
illuminated and may have various accessories.  
I.3250  External facial fracture fixation 
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 o r bone where 
weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and 
cement restrictor mesh used during orthopedic surgery.  
I.3500  Polytetrafluoroethylene with carbon 
fibers composite implant material  2 A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to 
be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves 
as a space -occupying substance and is shaped and formed by the surgeon to conform to the patient's need.  
I.3530  Silicone inflatable breast prosthesis  3 A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as 
polydimethylsilox ane 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.  138/222 
 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 amou nt 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 sili cone 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 in ner shell contains fixed amounts 
of cross -linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with 
sterile isotonic saline before or after implantation. The device is intended to be implanted to augmen t 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 polyd iphenylsiloxane, 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 compartmental izing the silicone gel. The device is intended to be implanted to augment or 
reconstruct the female breast.  
I.3550  Chin prosthesis  2 A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.  
I.3590  Ear prosthesis  2 An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.  
I.3610  Esophageal prosthesis  2 An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric 
material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal 
esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a 
device delivery s ystem.  
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 devi ce 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 b e 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 extre mity splint  1 An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.  139/222 
 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  impressions before molding an external 
prosthesis.  
I.4010  Tissue adhesive  2,3 (a)Tissue adhesive for the topical approximation of skin --(1)Identification: A tissue adhesive for the topical 
approximation of skin is a device intended for topical closure o f 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 stit ches.  
(2)Classification:Class 2.  
(b)Tissue adhesive for non -topical use --(1)Identification: A tissue adhesive for non -topical use, including 
adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic 
surger y, is a device used for adhesion of internal tissues and vessels.  
(2)Classification:Class 3.  
I.4011  Tissue adhesive with adjunct wound 
closure device for topical approximation 
of skin  2 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 closure device component maintains temporary skin edge alignment along the length of wound during 
application of the liquid a dhesive.  
Classification: Class 2.  
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 a bsorb 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. 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) additive  2 A woun d dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 
2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound 
packing.  140/222 
 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 devices that are intended for patients with class 3 burning wound, free sewing(replacing 
surgical suture), contain added drugs such as antimicrobial agents, added biologics such as growth factors,  or is 
composed of materials derived from animal sources. ；(2)Class 1 other devices.  
I.4020  Occlusive wound/burn  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.z  
Classification: (1)Class 2 de vices 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 -sterile 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 material in combination with water (at least 50 
percent) and capable of absorbing exudate.  
Classification: (1)Class 2 devices that are in tended 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 devi ces. 
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 intende d to be worn by operating room personnel during surgical procedures 
to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, 
and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe 
covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.  
Classification: (1)Class 2 devices intended for surgical proocedure including surgical gowns and surgical m asks. 
(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) 
performan ce requirements from the national standard CNS 14755(Z2125).  141/222 
 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.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, pediatri c 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 dev ice 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.  
Classification. Class II  
I.4350  Cryosurgical unit and accessories  2 (1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid 
nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by 
applying extreme cold.  
(2)Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous 
oxide cooled cryopro be and accessories is a device intended to destroy tissue during surgical procedures, including 
urological applications, by applying extreme cold.  
(3)Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and access ories. 
A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories 
is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended 
to treat disease con ditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of 
newly formed blood vessels) and various benign or malignant gynecological 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 
alopecia  2 A scalp cooling system to reduce the likelihood of chemotherapy -induced alopecia is a prescription device intended 
to reduce the frequency an d severity of alopecia during chemotherapy in which alopecia -inducing 
chemotherapeutic agents are used.  142/222 
 I.4370  Surgical drape and drape accessories  1,2 (a) A surgical 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 wound protector that may adhere to the skin around a surgical incision or be placed 
in a wound  to cover its exposed edges, and a latex drape with a self -retaining finger cot that is intended to allow 
repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. (b) 
Classification: (1) Class 2. (2) C lass 1 for drape and cover intended for medical device covering.  
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 accessories  2 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 for use 
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 surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs 
or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 
percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x -ray detectable 
elements.  
I.4460  Surgeon's glove.  1,2 A surgeon's glove is a device made of natural o r 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 barrier 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 sh ould 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  1,2 Surgeon's gloving cream is an ointment intended to be used to lubricate the user's hand before putting on a surgeon's 
glove.  143/222 
 I.4480  Absorbable powder for lubricating a 
surgeon's glove  3 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 suture  2 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 percentl -lactide, and is indicated for use in soft tissue approximation. A PGL suture mee ts United States 
Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" 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 technology  2 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.  
I.4495  Stainless steel suture  2 A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, 
in USP sizes 12 -0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal 
wound closure, intestinal an astomosis, 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 voca l 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 noninvasiv e use.  
Classification. Class II  
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.  144/222 
 I.4650  Aorto -saphenous vein ostia marker  2 An Aorto -saphenous vein ostia marker is used as a l andmark 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 sk in, e.g., to outline surgical incision 
sites or mark anatomical sites for accurate blood pressure measurement.  
I.4670  Internal tissue marker  2 An internal tissue marker is a prescription 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 apparatus  1 A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, 
disposabl e 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 
therapy  2 A non -powered suction apparatus device intended for negative pressure woun d 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 fluids, and infectious materials. It is further indicated for management of wounds, bu rns, flaps, 
and grafts.                                                                       
Classification. Class II  
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 
solvent  1 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 device intended to connect internal tissues to aid  healing. It is not absorbable.  
I.4760  Removable skin staple  1 A removable skin staple is a staple -like device intended to connect external tissues temporarily to aid healing. It is 
not absorbable.  
I.4780  Powered suction pump  2 A powered suction pump is a portable, AC -powered or compressed air -powered device intended to be used to 
remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The 
device may be used during surgery in the operating room or at the pa tient's bedside. The device may include a 
microbial filter.  145/222 
 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 sutur ing 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 
caliper s. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate 
regulations in parts 868 through 892.  
I.4810  Laser surgical instrument for use in 
general and plastic surgery and in 
dermatology  2 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.4820  Surgical instrument motors and 
accessories/attachments  1 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 hard tissue 
or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, 
dermatome, drill bit, hammerhead, pin driver, and saw blade.  
I.4830  Absorbable surgical gut suture  2 An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from 
eithe r the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) 
intestine, and is intended for use in soft tissue approximation.  
I.4840  Absorbable polydioxanone surgical 
suture  2 An absorbable polydioxanone surgica l 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 opht halmic 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 
accessories  1 A manual operating table and accessories and a manual operating chai r and accessories are nonpowered devices, 
usually with movable components, intended to be used to support a patient during diagnostic examinations or 
surgical procedures.  146/222 
 I.4960  Operating tables and accessories and 
operating chairs and accessories  1 Opera ting 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 suture  2 Nonabsorbable poly(ethylene terephthalate) 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 approximation. The poly(ethylene terephthalate) 
surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical 
Sutur es; 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 witho ut a standard needle attached.  
I.5010  Nonabsorbable polypropylene surgical 
suture  2 Nonabs orbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared 
from long -chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. 
The polypropylene surgical suture mee ts United States Pharmacopeia (U.S.P.) requirements as described in the 
U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color 
additive; and the suture may be provided with or without a standard needle atta ched.  
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. The polyamide 
surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for 
nonabsorbable surgical sutures; it may be monofilament or multifilament in  form; 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 Natu ral 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 speciesBombyx mori (B. mori ) of 
the familyBombycidae. Natural no nabsorbable silk surgical suture is indicated for use in soft tissue approximation. 
Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements 
for Nonabsorbable Surgical Suture (class I). Natural nonabso rbable 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.  
I.5035  Nonabsorbable expanded 
polytetrafluoroethylene surgical suture  2 Nonabsorbable expanded po lytetrafluoroethylene (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).  147/222 
 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 bottle 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 horsepower, a variable vacuum range from 0 to 29.9 inches of 
mercury, vacuum control valves to regulate the vacuum with accompanying vacu um 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 room  2 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 microorganisms 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 disruptio n of adipocyte cells within the 
fat layer for the release of fat and lipids from these cells for noninvasive  use.  
Classification. Class II  
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 apply 
humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin 
ulcers or bed sores.  
I.5900  Nonpneumatic tourniquet  1 A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's 
limb and tightened to reduce circulation.  
I.5910  Pneumatic tourniquet  1 A pneumatic tourniquet is an air -powered device consisting of a pressure -regulating unit, connecting t ubing, 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.  148/222 
 J.0001  Wound irrigation saline  2 Wound irrigation saline is a normal saline solution which uses physical means to clean the surface of a shall ow 
skin wound.  
J.0003  Elastic Pressure Garment  1 Elastic pressure garments 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 color changes of heat 
sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid cr ystals, 
which are cholesteric esters, are sealed in plastic.  
J.2420  Electronic monitor for gravity flow 
infusion systems  2 An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being 
infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, 
conditioning, and display.  
J.2460  Electrically powered spinal fluid 
pressure monitor  2 An electrically powered spinal fluid pressure monitor is an electricall y powered device used to measure spinal 
fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal. The device 
includes signal 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 into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure 
can be measured by reading the height of the fluid.  
J.2750  Image processing device for estimation 
of external blood loss  2 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 dev ice may include software and/or hardware that is used to process images 
capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.  149/222 
 J.2800  Sterilization process indicator  2 (a)Biological sterilization pro cess indicator --(1)Identification: A biological sterilization process indicator is a 
device intended for use by a health care provider to accompany products being sterilized through a sterilization 
procedure and to monitor adequacy of sterilization. The d evice consists of a known number of microorganisms, of 
known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent 
growth or failure of the microorganisms to grow under suitable conditions indicates th e 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 produ cts being sterilized through a 
sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the 
sterilization conditions as measured by these parameters is indicated by a visible change in the device. 
(2)Class ification: 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 unit. 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 A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The 
device may func tion 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.  
J.5090  Liquid bandage  1,2 A liquid bandage 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 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 so urces.；(2)Class 1 other devices.  150/222 
 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 height 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 in tended for medical purposes that consists of a bed with a manual 
mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes 
movable and latchable side rails.  
J.5130  Infant radiant warmer  2 The infant radiant 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 system (infant temperature, manual mode if 
present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual 
mode time limits, and device component failure, respectively. The devic e may be placed over a pediatric hospital 
bed or it may be built into the bed as a complete unit.  
J.5140  Pediatric medical crib  1 A pediatric medical crib is intended for medical purposes for use with a pediatric patient that consists of an open 
crib, fix ed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The 
contour of the crib surface may be adjustable.  
J.5150  Nonpowered flotation therapy mattress  1 A nonpowered flotation therapy mattress is a mattress intend ed 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 so res). 
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 exudat e, and to serve as a barrier against contaminants.  
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 shor t 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.  151/222 
 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 adhes ive 
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 disinfec tant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to 
support an injured part of the body, or to secure objects to the skin.  
Classification: (1)Class 2 devices that are intended for patients with class 3 burni ng 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 to cover and protect the eye of an infant during therapeutic procedures, 
such as phototherapy.  
J.5300  Medical absorbent fiber  1 A medical absorbent fiber is a device intended for medical purposes that is made from  cotton or synthetic fiber in 
the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids 
from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in thi s 
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 for water to add humidity, a control valve through which oxygen may be added, and access 
ports for nursing care.  
J.5410  Neonatal transport incubator  2 A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in 
which an infant may be kept in a controlled environment while being transported for medical care. The device may 
include straps to secure the infant, a battery -operated heater, an AC -powered battery charger, a fan to circulate the 
warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.  
J.5420  Pressure infusor for an I.V . 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 to give 
a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin 
and deliver the fluid to the body. It may be used for mass inoculations.  152/222 
 J.5440  Intravascula r 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 for burns or is 
lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans 
and air filters which maintain an atmosphere of clean air at a pressure greater than the ai r 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 m obile, 
used to lift and transport a patient in the horizontal or other required position from one place to another, as from a 
bed to a bath. The device includes straps and a sling to support the patient.  
J.5550  Alternating pressure air flotation 
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, freque nt, and automatic changes in the distribution of body pressure. The device is used to prevent 
and treat decubitus ulcers (bed sores).  
J.5560  Temperature regulated water mattress  1 A temperature regulated water mattress is a device intended for medical pur poses 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 ma nual 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 the 
body 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.  153/222 
 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 man ner. 
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 de vice 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 stoc king for 
general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure 
to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg. (2) 
Classificatio n: 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).  154/222 
 J.5860  Piston syringe  2 A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable 
plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a 
hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.  
J.5950  Umbilical occlusion device  1 An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessel s in the umbilical 
cord of a newborn infant.  
J.5965  Subcutaneous, implanted, intravascular 
infusion port and catheter  2 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 catheter. The device allows for repeated access to 
the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a 
portal body with a resealable septum and 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 catheter  2 A percutaneous, implanted, long -term intravascular catheter is a device that consists of a slender tube and any 
necessary connecting fittings, such as l uer 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 sampl ing 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 applica tor 1 An absorbent tipped applicator is a device 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 aerator cabinet is a device that is intended for use by a health care provider and consists of 
a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time 
required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO 
sterilization. The device may include a heater to warm the circulating air.  
J.6150  Ultrasonic cleaner for medical 
instruments  1 An ultrasonic cleaner for me dical 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.  155/222 
 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 patien t examination gloves 
should comply with the barrier property (water leak) and tensile strength requirements of ISO 11193 -1, ASTM D 
3578, ASTM D 5250, ASTM D 6319, EN 455 or equivalent standards.A non -powdered (powder free) patient 
examination glove should comply with residual powders requirements of EN ISO 21171, ASTM D 6124 or 
equivalent standards. The 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 symptoms of 
athlete's foot infection by absorbing moisture.  
J.6300  Implantable radiofrequency transponder 
system for patient identification and 
health information  2 An implantable radiofrequency transponder system for p atient 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 transpon der is used only to store a 
unique 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 pur poses that is used to issue a measured amount 
of liquid medication.  
J.6450  Skin pressure protectors  1 A skin pressure protector is a device intended for medical purposes that is used 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 device  2 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 su ction 
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 bo ttles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, 
specimen traps, noninvasive tubing, and suction regulators (with gauge).  
J.6775  Powered patient transfer 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.  156/222 
 J.6785 Manual patient transfer device  1 A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient 
can be placed so that the patient can be transferred with minimal disturbance in a horizo ntal 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, sterilization 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 pro ducts.  
J.6870  Dry-heat sterilizer  2 A dry -heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by 
means of dry heat.  
J.6880  Steam sterilizer  2 A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical 
products by means of pressurized steam.  
J.6885  Liquid chemical sterilants/high level 
disinfectants  2 A liquid chemical sterilant/high level disinfectant is a germicide that is intended for us e 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 lightw eight 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 d evice that uses a spring -loaded mechanism to drive a hypodermic needle into a 
patient to a predetermined depth below the skin surface.  157/222 
 J.6960  Irrigating syringe  1 An irrigating syringe is a device intended for medical purposes that consists of a bulb or a  piston syringe with an 
integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity 
or wound.  
J.6970  Liquid crystal vein locator  1 A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface 
temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).  
J.6980  Vein stabilizer  1 A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed 
on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted 
into the vein.  
J.6991  Medical washer  2 A medical washer is a device that is intended for general medical purposes to clean surgical instruments, anesthesia 
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 An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring 
the amount of swaying of the body when the patient is standing erect and with eyes closed.  
K.1200  Two-point  discriminator  1 A two -point discriminator is a device with points used for testing a patient's touch discrimination.  
K.1240  Echoencephalograph  2 An echoencephalograph is an ultrasonic scanning device (including A -scan, B -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.  158/222 
 K.1340  Nasopharyngeal electrode  2 A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the 
purpose of recording electrical activity.  
K.1350  Needle electrode  2 A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.  
K.1400  Electroencephal ograph  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 analyzer  1 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 visual ly 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 mecha nical 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 measuring 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 measuremen t 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 potential measurement device is a general diagnostic device used to measure skin voltage by means of 
surface skin electrodes.  
K.1570  Powered direct -contact temperature 
measurement device  2 A powered direct -contact temperature measurement device is a device which contains a power source and is used 
to measure differences in temperature between two points on the body.  
K.1580  Non-electroencephalogram (non -EEG) 
physiological signal based seizure 
monitori ng system  2 A non -electroencephalogram (non -EEG) physiological signal based seizure monitoring system is a noninvasive 
prescription device that collects physiological signals other than EEG to identify physiological signals that may be 
associated with a se izure.  
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.  159/222 
 K.1620  Intracranial pressure monitoring device  2 An intracranial pressure monitoring device is a device used for short -term monitoring and recording of intracranial 
pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.  
K.1630  Cranial motion measurement  device  2 A cranial motion measurement device is a prescription device that 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 arter y 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 electroenceph alogram).  
K.1845  Physiological signal conditioner  2 A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological 
signals for recording and processing.  
K.1855  Electroencephalogram   (EEG)   
telemetry system  2 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 used to apply an electrical stimulus to a patient by means of 
skin electrodes for the purpose of measuring the evoked response.  
K.1880  Evoked response mechanical 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 re sponse auditory stimulator is a device that produces a sound stimulus for 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 II  
K.1950  Tremor transducer  2 A tremor transducer is a device used to measure the degree of tremor caused b y 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.  160/222 
 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 inje ction 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 accessories  2 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 s kull. 
K.4305  Powered compound cranial 
drills,burrs,trephines,and their 
accessories  2 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 
accessories  2 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 wit h 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 procedure s. 161/222 
 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, spatulas, 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 procedures or in the repair of 
nervous tissue.  
K.4700  Cottonoid paddie  2 A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.  
K.4725  Radiofrequency lesion 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.  162/222 
 K.5050  Biofeedback dev ice 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 alpha 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 (balloonlike sacs formed on blood vessels) of intracranial 
blood vessels.  
K.5175  Cartoid artery clamp  2 A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in 
the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the ski n 
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 vascular malformations that are difficult to attach 
directly by reducing the  blood pressure and blood flow to the aneurysm or malformation.  
K.5200  Aneurysm clip  2 An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) 
to prevent it from bleeding or bursting.  
K.5225  Implanted malleable clip  2 An implanted malleable clip is a bent wire or staple that is forcibly closed with a special instrument to occlude an 
intracranial blood vessel or aneurysm (a balloonlike sac formed on a blood vessel), stop bleeding, or hold tissu e 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 surgeon uses to repair a skull 
defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a 
plate or other appropriate sh ape to repair the defect.  
K.5320  Preformed alterable cranioplasty plate  2 A preformed 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 changing 
the chemical behavior of the material.  163/222 
 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 a nd 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 tantalum, vitallium, or stainless steel used to 
secure a plate to the patient's skull to repair a skull defect.  
K.5500  Lesion temperature monitor  2 A lesion temperature monitor is a device used to monitor the tissue t emperature 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 
components  2 A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or 
other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of 
relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocep halus). 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 treatment  2 A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device 
used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the 
neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores 
blood flow in the neurovasculature.  
K.5800  Cranial electrotheraphy stimulator  3 A cranial electrotherapy stimulator is a device th at applies electrical current to a patient's head to treat insomnia, 
depression, or anxiety.  
K.5801  Computerized behavioral therapy device 
for psychiatric disorders  2 A computerized behavioral therapy device for psychiatric disorders is a prescription 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 t o therapy tools used during treatment sessions to improve recognized treatment outcomes.  
K.5805  Repetitive transcranial magnetic 
stimulation system  2 A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial re petitive 
pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat 
the symptoms of major depressive disorder.  
Classification. Class II  
K.5810  External functional neuromuscular 
stimulator  2 An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes 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 pat ient's gait.  164/222 
 K.5820  Implanted cerebellar stimulator  3 An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the 
treatment of intractable epilepsy, spasticity, and some movement disorders. The stimu lator consists of an implanted 
receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the 
stimulating pulses across the patient's skin to the implanted receiver.  
K.5830  Implanted diaphragmatic/phr enic nerve 
stimulator  3 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 p hrenic 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 relief  3 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 externa l transmitter for transmitting the stimulating 
pulses across the patient's skin to the implanted receiver.  
K.5850  Implanted spinal cord stimulator for 
bladder evacuation  3 An implanted spinal cord stimulator for bladder evacuation is an electrical stimula tor 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 o f 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 t he heel in the patient's shoe.  
K.5870  Implanted peripheral nerve stimulator for 
pain relief  2 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 inplanted receiver with electrodes 
that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across 
the patient's skin to the implanted receiver.  165/222 
 K.5880  Implanted spinal cord stimulator for 
bladder evacuation  2,3 (a) 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. (b) 
Classification: (1) Class 2 for devices intended to treat body/limbs cronical or intractable pain, (2) Class 3 for other 
devices (e.g., intended to t reat pain caused from failed back surgery syndrome).  
K.5890  Transcutaneous electrical nerve 
stimulator for pain relief  2 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 prescription 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 prescription 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 prescription 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 disorders  2 A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to 
aid in the reduction of wi thdrawal symptoms associated with substance use disorders.  
K.5897  External upper limb tremor stimulator  2 An external upper limb tremor stimulator is a prescription 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 fused 
together.  
K.5910  Dura substitute  2 A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).  
K.5940  Electroconvulsive therapy 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  Artifici al embolization device  3 A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to 
cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other 
embolic agents , which act by polymerization or precipitation. Embolization devices used in other vascular 
applications are also not included in this classification, see 870.3300.  166/222 
 K.5960  Skull tongs for traction  2 Skull tongs for traction is an instrument used to immobi lize 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 positi on. 
K.5970  Cranial orthesis  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 devide 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  Absorable adhesion barrier  3 An absorbabl e adhesion barrier is used for patients undergoing open gynecologic surgery. This device is intended 
to reduce the likelihood of developing  postoperative adnexal adhesions 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 c hronic 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 de vice 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 cu rette 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 for menstrual 
extraction. This generic type of device may include cathete rs, syringes, and tissue filters or traps.  167/222 
 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 
accessories  2 A 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 -filled sack for intravaginal use that is attached to an external 
manome ter. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary 
contractions of these muscles and is used to diagnose and to correct, through exercise, uninary 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 dis posable 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 wi th 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 accessories  3 A transabdominal amnioscope is a dev ice 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 compo nent parts.  168/222 
 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 telescopic 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, connectors, 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), ligature 
carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, lig ature 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 accessories  2 A transcervical endoscope is a device designed to permit direct viewing of the fetus and amniotic sac by means of 
an open tube introduced into the uterus through the cervix. The device may be used to visualize the fetus or 
amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, 
instruments used through an operating channel, 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 used to perform diagnostic and surgical 
procedures other than sterilization. Thi s 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 sources. Such hysteroscope accessory instruments include: lens cleaning 
brush, ca nnula (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 dis tend 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 tubing/filter fits which only include accessory 
instruments that are not used to ef fect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single -
use tubing kits used for only intrauterine insufflation.  169/222 
 L.1710  Closed loop hysteroscopic insufflator 
with cutter -coagulator  2 A closed loop hysteroscopic insufflator with cutter -coagulator is a prescription 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 recirculat ing 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  Gyne cologic 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 introduced through the abdominal wall. It is used to perform diagnostic an d 
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) C lass 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 gynec ologic laparosope accessory instruments include: the 
lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), 
ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligatur e passing and knotting 
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) Identification: A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the 
peritoneal cavity with gas to distend it.  
(b) Classification: (1) Class 2; (2) Class 1: Tubing and tubing/filter kits which include accessor y instruments that 
are not used to effect intra -abdominal insufflation (pneumoperitoneum).  
L.2050  Obstetric data analyzer  3 An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data 
obtained fr om 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 
signal analysis and display equipment, elec tronic 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 femal e 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 followi ng: 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 used to monitor the changes in some physiological condition over long periods of time.  170/222 
 L.2600  Fetal cardiac monitor  2 A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is 
designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals 
(electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal 
abdomen with external electrodes. This generic type of device may include an alarm that signals when th e 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 phono cardiographic monitor and 
accessories  2 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 ty pe 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 ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant 
woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some 
physiological condition or characteristic in a measured 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 equipment, 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 condition, 
but does include devices which may  be set to alarm automatically at a predetermined threshold value.  
L.2675  Fetal scalp circular   spiral   electrode 
and applicator  2 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 electrod es 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.  171/222 
 L.2700  Intrauterine pressure monitor and 
accessories  2 An intrauterine pressure mon itor 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 uterine 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 
accessories  2 An external uterine contraction mo nitor (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 incl ude 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 measurement 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 monitor that receive , process, and display data. This device is intended for use in women with a 
previous preterm delivery to aid in the detection of preterm labor.  
L.2740  Perinatal monitoring system and 
accessories  2 A perinatal monitoring system is a device used to show gr aphically the relationship between maternal labor and 
the 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. T his generic type of 
device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 
884.2720. This generic type of device may include the following accessories: Central monitoring system and 
remote repeaters, signal a nalysis 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 m atrix 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, bu t also through the user's head by tissue conduction 
into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference 
commonly caused by handling conventional stethoscopes.  172/222 
 L.2960  Obstetric ultrasonic transdu cer 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 
ultraso nic 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 c ables, 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 Identification: 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 supports, component 
parts, and accessories.  
Classification: (1) Class 1 devices intended for adjunctive diagnostic screening for detec tion 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 thermogr aphic 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 pal pation 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 include 
patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, 
component parts, and accessories.  
(2)Classif ication. Class I (general controls).  
L.3200  Cervical drain  2 A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic 
surgery.  
L.3575  Vaginal pessary  2 A vaginal pessary is a removable structure  placed in the vagina to support the pelvic organs and is used to treat 
conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or 
gynecologic hernia.  
L.3650  Fallopian tube prosthesis  2 A fallopian tube  prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is 
used after reconstructive surgery.  
L.3900  Vaginal stent  2 A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft 
after reconstructive surgery.  173/222 
 L.4050  Gynecologic laparoscopic power 
morcellation containment system  2 A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an 
instrument port and tissu e containment method that creates a working space allowing for direct visualization during 
a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue 
that is not suspected to contain malignancy.  
L.4100  Endoscopic electrocautery and 
accessories  2 An endoscopic electrocautery is a device used to perform female sterilization under endoscopic observation. It is 
designed to coagulate fallopian tube tissue with a probe heated by low -voltage energy. This generi c 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 
genera tor, a probe, and electrical cables.  
L.4150  Bipolar endoscopic coagulator -cutter and 
accessories  2 A bipolar endoscopic coagulator -cutter is a device used to perform female sterilization and other operative 
procedures under endoscopic observation. It dest roys 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 electrica l cables.  
L.4160  Unipolar endoscopic coagulator -cutter 
and accessories  2 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 cabl es, 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 han dles and two opposing blades used manually to dilate 
(stretch open) the cervical os.  
L.4260  Hygroscopic Laminaria cervical dilator  2 A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical 
insertio n of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria 
japonica). The device is used to induce abortion.  
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.  174/222 
 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 scalp and is powered by an external vacuum 
source. This generic ty pe of device may include the cup, hosing, vacuum source, and vacuum control.  
L.4350  Fetal head elevator  2 A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate 
delivery during a Caesarean secti on. 
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 destructi ve hook.  
L.4520  Obstetric -gynecologic general manual 
instrument  1 An obstetric -gynecologic general manual instrument is one of a group of devices used to perform simple obstetric 
and gynecologic manipulative functions. This generic type of device consists  of the following:  
(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of 
the vulvar orifice for obstetrical purposes.  
(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberopt ic light, used to expose and illuminate 
the interior of the vagina.  
(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.  
(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to c ut 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 applicator is an instrument used to insert medicat ion 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.  175/222 
 L.4530  Obstetric -gynecologic specialized 
manual instrument  1,2 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 fol lowing:  
(1) An amniotome is an instrument used to rupture the fetal membranes.  
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male 
infant.  
(3) An umbilical clamp is an instrument used to compre ss 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 series 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 blades and handles used to pull, grasp, or compress 
during gynecological examination.  
(8) A  cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.  
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.(10) A hook -type 
contraceptive intrauterine device (IUD) remover is an ins trument 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 to determine the depth of the uterus by inserting it into the uterine cavity.  
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the 
surface of the cervix or vagina.  
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy 
proce dures.  
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus . 
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the 
pelvis.  
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.  
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and 
illuminate the interior of the vagina.  
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.  176/222 
 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 exa mine 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 control s. 
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 pre ssure wedge  2 A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and 
delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of 
external hemorrh oids associated with vaginal childbirth.  
Classification. Class II  
L.5210  Pressure wedge for the reduction of 
cesarean delivery  2 A pressure wedge for the reduction of cesarean delivery is a prescription 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 cap is a flexible cuplike receptacle that fits over the cervix to collect m enstrual flow or to aid artificial 
insemination. This generic type of device is not for contraceptive use.  
L.5300  Condom  2 A condom is a sheath which completely covers the penis with a closely fitting 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 device may contain lubricants 
compatible for use with condoms.  177/222 
 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 
prophylact ic 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  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 vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is remov ed 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 pla ced 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 introducer  3 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. Thi s generic type 
of device includes the introducer, but does not include contraceptive IUD's that function by drug activity, which 
are subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act (see 310.502).  
L.5380  Contraceptive tubal o cclusion device 
(TOD) and introducer  3 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 t he 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 used 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.  178/222 
 L.5460  Scen ted or scented deodorized menstrual 
tampon  2 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 h as 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 device 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 fill ing the therapeutic vaginal douche apparatus 
with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.  
Classification:(1) Class 2 ；(2) Class 1 devices operated by gravity.  
L.5920  Vaginal insufflator  1 A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand -held bulb 
into the vagina through an open speculum.  
L.5940  Powered vaginal muscle stimulator for 
therapeutic use  3 A powered vaginal muscle stimulator is an electr ically 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 tre atment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic 
floor to increase muscle tone).  
L.5970  Clitoral engorgement device  2 A clitoral engorgement device is designed to apply a vacuum to the clitoris. It  is intended for use in the treatment 
of female sexual arousal disorder.  
L.5980  Surgical mesh for transvaginal pelvic 
organ prolapse repair  3 Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft t issue 
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.  179/222 
 L.6100  Assisted reproduction needles  2 Assisted reproduction needles are devi ces 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 de vice may include a single 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, dila tors, 
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 assiste d reproduction catheters, 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 (p owered or manual) used to 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 stage 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 instrumenta tion and devices, used to contain, 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 instruments  2 Assisted reprod uction 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 microinjectors  2 Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction 
microtool. Assisted reproduction microinjectors are any device intended to control aspirat ion or expulsion of the 
contents of an assisted reproduction microtool.  180/222 
 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 c ome into physical contact with gametes, embryos or tissue culture 
media.  
L.6165  Intravaginal culture system  2 An intravaginal culture system is a prescription device intended for preparing, holding, and transferring human 
gametes or embryos during intrava ginal in vitro fertilization or intravaginal culture procedures.  
L.6170  Assisted reproduction water and water 
purification systems  2 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. Medi a include 
liquid and powder versions of 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 purposes 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 reproductiv e microscopes and 
microscope accessories  1 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 gam etes or 
embryos. Variations of microscopes and accessories used for these purposes would include phase contrast 
microscopes, dissecting microscopes and inverted stage microscopes.  
L.6195  Assisted Reproduction Embryo Image 
Assessment System  2 An Assisted Reproduction Embryo Image Assessment System is a prescription 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 mul tiple 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 t angential hole in, or to thin, the zona pellucida of an embryo for assisted 
hatching or other assisted reproduction procedures.  181/222 
 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 between the lacrimal sac and the nasal 
cavity). It includes a light source, controls/foot -switch, monitoring system, and probes.  
M.0002  Endocapsular ring  3 An endocapsular ring is an ophthalmic device for placem ent 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 punctum plug is an ophthalmological device designed to be inserted through the punctal opening into 
the canaliculus in order to block tear drainage through the lacrimal drainage system.  
M.1040  Ocular esthesiometer  1 An ocular esthesiometer is a device, such as a single -hair brush, intended to touch the cornea  to assess corneal 
sensitivity.  
M.1050  Adaptometer (biophotometer)  1 An adaptometer (biophotometer) is an AC -powered device that provides a stimulating light source which has 
various controlled intensities intended to measure the time required for retinal  adaptation (regeneration of the 
visual purple) and the minimum light threshold.  
M.1070  Anomaloscope  1 An anomaloscope is an AC -powered device intended to test for anomalies of color vision by displaying mixed 
spectral lines to be matched by the patient.  
M.1090  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 illu minate 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).  182/222 
 M.1250  Euthyscope  1,2 A euthyscope is a device that is a modified AC -powered or battery -powered ophthalmoscope (a perforated mirror 
device in tended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 
degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea 
(the central depression of the macular retinae 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).  
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 which the patient indicates the positions of afterimages after the light is off. The device is 
intended to determine harmonious/anomalous retinal correspondence (the condition in which corresponding points 
on the retina have the same 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 strabi smus (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 prescription 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 inte nded to measure and evaluate the corneal curvature 
of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of 
device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.  
M.1360  Visual field laser instrument  2 A visual field laser instrument is an AC -powered device intended to provide visible laser radiation that produces 
an interference pattern on the retina to evaluate retinal function.  
M.1375  Bagolini lens 1 A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not 
obscure visualization of objects. The device is placed in a trial frame and intended to determine 
harmonious/anomalous retinal correspon dence (a condition in which corresponding points on the retina have the 
same directional values).  183/222 
 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 from the fundus of the 
eye. 
M.1385  Polymethylmethacrylate (PMMA) 
diagnostic contact lens  2 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 devi ce that is a very thin lens which has its surface a concentric series of 
increasingly refractive zones. The device is intended to be applied to the back of the spectacle lenses of patients 
with aphakia (absence of the lens of the eye).  
M.1395  Diagnostic H ruby 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 len s set is a device that is a set of lenses of various dioptric powers intended to be handheld 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 AC -powered device intended to measure corneal size by superimposing 
the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye  
gauge magnifier.  
M.1460  Stereopsis measuring instrument  1 A stereopsis 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 optics 
intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.  184/222 
 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 per ceptual 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 
stimulation 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 gen erated 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 is otope 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 e ye 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.  185/222 
 M.1760  Ophthalmic refractometer  1 An ophthalmic refractometer is an automatic AC -powered device that consists of a fixation system, a measurement 
and recording system, and an alignment system intended to measure the refractive power of the eye by measuring 
light reflexes from the retina.  
M.1770  Manual refractor  1 A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive 
error of the eye.  
M.1780  Retinoscope  1,2 A retinoscope is an AC -powered or battery -powered device intended to measure the refraction of the eye by 
illuminating the retina and notin g the direction of movement of the light on the retinal surface and of the refraction 
by the eye of the emergent rays.  
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 evaluat e 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 flat surface the central 30 degrees  of a patient's visual field. This 
generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, 
and stereo campimeters.  
M.1850  AC-powered slitlamp 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), a nd 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 devic e, 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, prescription device incorporating a telemetric sensor to 
detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.  186/222 
 M.1930  Tonometer and accessories  2 A tonometer and accessories is  a manual device intended to measure intraocular pressure by applying a known 
force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure 
intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include 
a tonometer calibrator or a tonograph 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 -powered device that is a light source intended to transmit light 
through tissues to aid examination of patients.  
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 device 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 An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or pl astic, 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 intended to be implanted during scleral surgery for 
buckling or building up the floor of the eye, usua lly in conjunction with retinal reattachment. Injectable substances 
are excluded.  
M.3400  Keratoprosthesis  2 A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either 
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.380 0 Scleral shell  1 A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the 
cornea and proximal -cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on 
the device. The device is not intended to be implanted.  
M.3920  Eye valve implant  2 Eye valve implant is an implantable one -way pressure sensitive valve intended to reduce intraocular pressure in 
the anterior chamber of the eye. This device is for patients wit h glaucoma.  187/222 
 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 
apparatus  2 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 cl osure 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 cryophthalmic unit is a device that is a probe with a small tip that becomes extremely col d 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.  
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 ey e 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 o r 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 remov ed 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.  188/222 
 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 the manual corn eal 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, ophthalmic 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, ophthalmic spatu la, 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 ophthalm ic 
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 energ y, high power, coherent optical radiation. When the laser output is 
combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A 
visible aiming system is utilized to target the invisible Nd:YAG laser ra diation on or in close proximity to the target 
tissue.  
M.4400  Electronic metal locator  2 An electronic metal locator is an AC -powered device with probes intended to locate metallic foreign bodies in the 
eye or eye socket.  
M.4570  Ophthalmic surgical marke r 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 dial 
indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.  
M.4670  Phacofragmentation system  2 A phacofragmentation system is an AC -powered device with a frag menting 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 nonco herent 
light source to occlude blood vessels of the retina, choroid, or iris.  189/222 
 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 devic e 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 
deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to 
control the application of heat and pressure to the eyelids.  
Classification. Class II  
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 symptoms  2 An intranasal electrostimulation device for dry eye symptoms is a prescripti on non -implantable, electrostimulation 
device 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 -intensity focused ultrasound (HIFU) energy in the ciliary body and trabecular meshwork. This 
device is designed to treat refractory glaucoma.  
M.5600  Ptosis crutch  1 A ptosis crutch is a device intended to be m ounted 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 prescription device made of gold, tantalum, plat inum, 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).  
M.5838  Nasolacrimal compression device  1 A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal 
aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.  190/222 
 M.5844  Corrective spectacle lens  1 A corrective specta cle 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 sung lass lenses may be reflective, tinted, polarizing, or photosensitized. 
Products made with this corrective spectacle lens include corrective and protective sports goggles, such as 
swimmers ’ goggles, ski goggles, racquetball eye guards, and diving goggles.  
M.5905  Oral electronic vision aid  2 An oral electronic vision aid is a battery -powered prescription device that contains an electrode 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 elastomers, whose ma in polymer molecules generally do not absorb or attract water.  
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/rewet ting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used 
together with rigid gas permeable contact lenses.Classification:(1)Class 1 contact lens container. ;(2)Class 2 other 
devices.  
M.5925  Soft (hydrophilic) contact 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 
polym er materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 
water. 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 includes all solutions and tablets used 
together with soft (hyd rophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) 
contact lens by means of heat. Classification:(1)Class 1 contact lens container. ;(2)Class 2 other devices.  
M.9999  Others(Ophthalmic Devices)  1,2,3  The products excluded from the above -classification are adopted in this classification and specified by the central 
competent health authority.  
N.0001  Orthopedic extracorporeal shock wave 
system  3 An orthopedic extracorporeal shock wave therapy system is a th erapy system for orthopedic diseases. This device 
can be used only by health professionals.  
N.0003  Intraarticular hyaluronic acid implants  3 Intra -articular hyaluronic acid implants are hyaluronic acid used for intra -articular injections.  191/222 
 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 forming 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 to perf orm surgery within a joint.  
N.1240  AC-powered dynamometer  2 An AC -powered dynamometer is an AC -powered device intended for medical purposes to assess neuromuscular 
function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force 
into electrical impulses), the grip -strength of a patient's hand.  
N.1250  Nonpowered dynamometer  1 A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip 
muscle strength of a  patient's hand.  
N.1500  Goniometer  1,2 Identification: A goniometer is an AC -powered or battery powered device intended to evaluate joint function by 
measuring and recording ranges of motion, acceleration, or forces exerted by a joint.  
Classification: (1) Class 1 devices that does not use electrode lead wires and patient cables. ；(2) Class 2 devices 
that uses electrode lead wires and patient cables.  
N.1520  Nonpowered goniometer  1 A nonpowered goniometer is a mechanical device intended f or medical purposes to measure the range of motion 
of joints.  
N.3000  Bone cap  1 A bone cap is a mushroom -shaped device intended to be implanted made of either silicone elastomer or ultra -high 
molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to 
control bone overgrowth in juvenile amputees.  
N.3010  Bone fixation cerclage  2 A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt -chromium -
molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft 
of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.  
N.3015  Bone heterograft  3 Bone heterograft is a device intended to be implanted that is made from mature (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 t o 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 prescription implanted device consisting of a balloon that is 
inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and 
completely encapsulates, a  liquid monomer that is exposed to a curing agent which polymerizes the monomer 
within the balloon creating a hardened rigid structure.  192/222 
 N.3025  Passive tendon prosthesis  2 A passive tendon prosthesis is a device intended to be implanted made of silicon ela stomer 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 growth 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 
cement  2 Polymethylmethacrylate (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 accessories  2 Single/multiple compone nt 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 a re 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 pr oximal or distal 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 a ttached through 
the skin so that a pulling force (traction) may be applied to the skeletal system.  
N.3040  Smooth or threaded metallic bone 
fixation fastener  2 A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that c onsists 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, slotted 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 sk eletal system.  
N.3045  Resorbable calcium salt bone void filler 
device  2 A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the 
extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony 
structure.  193/222 
 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 v arious hooks and a posteriorly placed compression or distraction rod. The device is implanted, 
usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and 
fuse the vertebrae together. The device 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 u sed 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  2,3 (a) Pedicle screw spinal systems are multiple component devices, made from a variet y 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 to build an implant system to fit the patient's anatomical and 
physiological req uirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, 
hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal 
members (e.g., plates, rods, and/or plate/rod combina tions); and/or transverse connectors.(b) Classification: (1) 
Class 2  for devices that comply with the following listed special controls (comply with material standards, comply 
with mechanical testing standards, and comply with biocompatibility standards). (2) Class 3  for pedicle screw 
spinal systems intended for other purposes.  
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, includ ing 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.  
N.3100  Ankle joint metal/composite semi -
constrained cemented prosthesis  2 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 ac ross-the-joint. 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 wi th carbon fibers composite, and is limited 
to those prostheses intended for use with bone cement (N.3027).  194/222 
 N.3110  Ankle joint metal/polymer semi -
constrained cemented prosthesis  2 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 t hat have a talar 
resurfacing component made of alloys, such as cobalt -chromium -molybdenum, and a tibial resurfacing component 
made of ultra -high molecular weight polyethylene and is limited to those prostheses intended for use with bone 
cement (N.3027).  
N.3120  Ankle joint metal/polymer non -
constrained cemented prosthesis  3 An ankle joint metal/polymer non -constrained cemented prosthesis is a device intended to be implanted to replace 
an ankle joint. The device limits minimally (less than normal anatomic co nstraints) translation in one or more 
planes. It has no linkage across -the-joint. This generic type of device includes prostheses that have a tibial 
component made of alloys, such as cobalt -chromium -molybdenum, and a talar component made of ultra -high 
mole cular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).  
N.3150  Elbow joint metal/metal or 
metal/polymer constrained cemented 
prosthesis  2 An elbow joint metal/polymer constrained cemented prosthesis is a  device intended to be implanted to replace an 
elbow joint. It is made of alloys, such as cobalt -chromium -molybdenum, or of these alloys and of an ultra -high 
molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic p lane 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 (888.3027).  
N.3160  Elbow joint metal / polymer semi -
constrained cemented prosthesis  2 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 ty pe of device is limited to those prostheses 
intended for use with bone cement (888.3027).  
N.3170  Elbow joint radial (hemi -elbow) polymer 
prosthesis  2 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 prosthesis  3 An elbow joint humeral (hemi -elbow) metallic uncemented prosthesis is a device intended to be implanted made 
of alloys, such as cobalt -chromium -molybdenum, that is used to replace the distal end of 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 ce ment (888.3027).  195/222 
 N.3200  Finger joint metal / metal constrained 
uncemented prosthesis  3 A finger joint metal/metal constrained uncemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one 
anatomic 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 protheses made from allo ys and ultra -high 
molecular weight polyethylene. This generic type of device is limited to prostheses intended for use without bone 
cement (888.3027).  
N.3210  Finger joint metal / metal constrained 
cemented prosthesis  3 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 
(888.3027).  
N.3220  Finger joint metal / polymer constrained 
cemented prosthesis  3 A finger joint metal/p olymer constrained cemented prosthesis is a device intended to be implanted to replace a 
metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one 
anatomic plane, and consists of two components which a re 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 (888.3027).  
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 prost heses 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 prosthesis  3 A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a 
hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked 
together. This generic type of device includes prostheses that have components made of alloys, such as cobalt -
chromium -molybdenum, and is intended for use with or without bone cement (888.3027). This device is not 
intende d for biological fixation.  
N.3310  Hip joint metal/polymer constrained 
cemented or uncemented prosthesis  2 A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to 
replace a hip joint. The device preve nts 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 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 (888.3027).  196/222 
 N.3320  Hip joint met al/metal semi -constrained, 
with a cemented acetabular component, 
prosthesis  3 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, s uch as cobalt -chromium -
molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement 
(888.3027).  
N.3330  Hip joint metal/metal semi -constrained, 
with an uncemented acetabular 
component, prosthesis  3 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 su rfaces. 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 b one cement. The acetabular 
component is intended for use without bone cement (888.3027).  
N.3340  Hip joint metal/composite semi -
constrained cemented prosthesis  2 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 f emoral component made of alloys, such as cobalt -chromium -molybdenum, and an acetabular component 
made of ultra -high molecular weight polyethylene with carbon fibers composite. Both components are intended 
for use with bone cement (888.3027).  
N.3350  Hip jo int metal/polymer semi -
constrained cemented prosthesis  2 A hip joint metal/polymer semi -constrained cemented prosthesis is a device intended to be implanted to replace a 
hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating 
surfaces. It has no linkage across -the-joint. This generic type of device includes prostheses that have a femoral 
component made of alloys, such as cobalt -chromium -molybdenum, and an acetabular resurfacing component made 
of ult ra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement 
(888.3027).  197/222 
 N.3353  Hip joint metal / ceramic / polymer semi -
constrained cemented or nonporous 
uncemented prosthesis  2 A hip joint metal/ceramic/poly mer 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 with 
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 nonpo rous metal alloys, and used with or without bone cement.  
N.3358  Hip joint metal / polymer / metal semi -
constrained porous -coated uncemented 
proshesis  2 A hip joint metal/polymer/metal semi -constrained porous -coated uncemented prosthesis is a device intend ed 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 cob alt-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 v olume porosity 
between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a 
porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve 
biological fixation to bone without the use of bone cement.  
N.3360  Hip joint femoral(hemi -hip)  metallic 
cemented or uncemented prosthesis  2 A hip joint femoral (hemi -hip) metallic cemented 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 (888.3 027) 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 prosthesis  3 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 (888.3027).  198/222 
 N.3380  Hip joint femoral(hemi -hip) trunnion -
bearing metal/polyacetal cemented 
prosthesi s 3 A hip joint femoral (hemi -hip) trunnion -bearing metal/polyacetal cemented prosthesis is a two -part device intended 
to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that 
consist of a 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. The head 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 (888.3027).  
N.3390  Hip joint femoral(hemi -hip) 
metal/polymerl  cemented or uncemented  
prosthesis  2 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 th at 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 weight polyethylene. This 
generic type of device may be fixed  to the bone with bone cement (888.3027) or implanted by impaction.  
N.3400  Hip joint femoral(hemi -hip) metallic 
resurfacing prosthesis  2 A hip joint femoral (hemi -hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a 
porti on 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 
prosthesis  3 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 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 
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 (888.3027).  
N.3480  Knee joint femorotibial metallic 
constrained cemented prosthesis  3 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 (888.3027).  199/222 
 N.3490  Knee joint femorotibial metal/composite 
non-constrained cemented prosthesis  2 A knee joint femorotibial metal/composite non -constrained cemented prosthesis is a device intended to be 
implanted to replace part o f 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 condylar component or components made of ultra -high molecular weight polyethylene 
with carbon fibers composite and are intended for use with bone cement (888.3027).  
N.3500  Knee joint femorotibial metal/composite 
semi -constrained cemented prosthesis  2 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 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 have a femoral component made of alloys, such as cobalt -chromium -molybdenum, an d 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 (888.3027).  
N.3510  Knee joint femorotibial metal/polymer  
constrained cemented prosthesis  2 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 compone nts 
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 tibi al condyles. The ball -and-socket 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 femoral component and 
flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is 
made of an alloy, such as cobalt -chromium -moly - bdenum, but the socket of the component is made of ultra -high 
molecula r weight polyethy - lene. The femoral component has metallic runners which align with the ultra -high 
molecular weight polyethylene tracks that press -fit into the metallic tibial component. The generic class also 
includes devices whose upper and lower compon ents 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 (888.3027).  200/222 
 N.3520  Knee joint femorotibial metal/polymer 
non-constrained cemented prosthesis  2 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 molecular weight polyethylene and are intended for use 
with bone cement (888.3027).  
N.3530  Knee joint femorotibial metal/polymer 
semi -constrained cemen ted prosthesis  2 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 art iculating 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 polye thylene and is limited to those prostheses intended for use with bone 
cement (888.3027).  
N.3535  Knee joint femorotibial  
unicompartmental   mental/polymer 
porous -coated uncemented prosthesis  2 A knee joint femorotibial (uni -compartmental) metal/polymer po rous-coated uncemented prosthesis is a device 
intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more 
planes via the geometry of its articulating surface. It has no linkage across -the-joint. This generic type of device is 
designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed -
bearing knee prostheses where the ultra -high molecular weight polyethylene tibial bearing is rigidly secured to the  
metal tibial baseplate.  
N.3540  Knee joint patellofemoral polymer/metal 
semi -constrained cemented prosthesis  2 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 rotation in one or more planes via the geometry of its articulating surfaces. It has 
no linkage across -the-joint. This generic type of de vice includes a component made of alloys, such as cobalt -
chromium -molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the 
anterior aspect of the distal femur, and a patellar component made of ultra -high molecular we ight polyethylene. 
This generic type of device is limited to those devices intended for use with bone cement (888.3027). The patellar 
component is designed to be implanted only with its femoral component.  201/222 
 N.3550  Knee joint patellofemorotibial 
polymer/meta l/metal constrained 
cemented prosthesis  3 A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be 
implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and  has 
components that are linked together. This generic type of device includes prostheses that have a femoral 
component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, 
such as cobalt -chromium -molybdenu m, and a retropatellar resurfacing component made of ultra -high molecular 
weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a 
metallic screw or bone cement. All stemmed metallic components within  this generic type are intended for use 
with bone cement (888.3027).  
N.3560  Knee joint patellofemorotibial 
polymer/metal/polymer semi -constrained 
cemented prosthesis  2 A knee joint patellofemorotibial polymer/metal/polymer semi -constrained cemented prosthesis is a device intended 
to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the 
geometry of its articulating surfaces. It has no linkage across -the-joint. This generic type of device include s 
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 l imited to those prostheses intended for use with bone cement 
(888.3027).  
N.3565  Knee joint patellofemorotibial 
metal/polymer porous -coated 
uncemented prosthesis  2 A knee joint patellofemorotibial metal/polymer porous -coated uncemented prosthesis is a devi ce 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 weight polyethylene tibial bearing is rigidly secured to the metal tibial 
base plate.  
N.3570  Knee joint femor al (hemi -knee) metallic 
uncemented prosthesis  3 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 tran slation 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 enhanc ement of fixation and is limited to those prostheses intended for use without bone cement (888.3027).  202/222 
 N.3580  Knee joint patellar (hemi -knee) metallic 
resurfacing uncemented prosthesis  2,3 A knee joint patellar (hemi -knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as 
cobalt -chromium -molybdenum, intended to be implanted to replace the retropatellar articular 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 t hose prostheses intended for use without bone cement (888.3027).  
N.3590  Knee joint tibial (hemi -knee) metallic 
resurfacing uncemented prosthesis  2 A knee joint tibial (hemi -knee) metallic resurfacing uncemented prosthesis is a device intended to be implan ted 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 prosthesis is made of alloys, such as cobalt -chromium -
molybdenum, and is in tended to resurface one tibial condyle. The generic type of device is limited to those 
prostheses intended for use without bone cement (888.3027).  
N.3640  Shoulder joint metal/metal or 
metal/polymer constrained cemented 
prosthesis  3 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. This generic type of devic e 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 generic type of device is l imited 
to those prostheses intended for use with bone cement (888.3027).  
N.3650  Shoulder joint metal / polymer non -
constrained cemented prosthesis  2 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 allo ys, 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 
(888.3027).  
N.3660  Shoulder joint metal/polymer semi -
constra ined cemented prosthesis  2 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 of its 
articu lating 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 molecu lar weight polyethylene, and is limited to those prostheses intended for use 
with bone cement (888.3027).  203/222 
 N.3670  Shoulder joint metal/polymer/metal 
nonconstrained or semiconstrained 
porous -coated uncemented prosthesis  2 A shoulder joint metal/polymer/metal nonconstrained or semi -constrained porous -coated uncemented prosthesis is 
a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. 
It has no linkage across -the-joint. This generic type of device includes prostheses that have a humeral component 
made of alloys such as cobalt -chromium -molybdenum (Co -Cr-Mo) and titanium -aluminum -vanadium (Ti -6Al-
4V) alloys, and a glenoid resurfacing component made of ultra -high molecular weight polyeth ylene, 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 co mponents, 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 porosit y 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 prosthesis  3 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 (888.3027).  
N.3690  Shou lder joint humeral (hemi -
shoulder)metallic uncemented prosthesis  2 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 i mplanted to replace the 
articular surface of the proximal end of the humerus and to be fixed without bone cement (888.3027). 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 silicone elastomer or polyester reinforced silicone 
elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of 
device consists of a single flexible across -the-joint component that prevents dislocation in more than one anatomic 
plane.  
N.3730  Toe joint phalangeal (hemi -toe)polymer 
prosthesis  2 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.  204/222 
 N.3770  Wris t 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 w rist. 
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 
prosthesis  3 A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to r eplace 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 components linked together. This generic type of device is limited to a device which 
is made of  alloys, such as cobalt -chromium -molybdenum, and is limited to those prostheses intended for use with 
bone cement (888.3027).  
N.3800  Wrist joint metal/polymer semi -
constrained cemented prosthesis  2 A wrist joint metal/polymer semi -constrained cemented pro sthesis 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 devices have a metacarpal component(s) made of 
alloys, such as cobalt -chromium -molybd enum. This generic type of device is limited to those prostheses intended 
for use with bone cement (888.3027).  
N.3810  Wrist joint ulnar(hemi -wrist) polymer 
prosthesis  2 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 measuring 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 (888.3027) 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 
(888.3027).  205/222 
 N.4220  Cement monomer vapor evacuator  1 A cement monome r vapor evacuator is a device intended for use during surgery to contain or remove undesirable 
fumes, such as monomer vapor from bone cement (888.3027).  
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 (888.3027).  
N.4300  Depth gauge for clinical use  1 A depth gauge for clinical use is a measuring device inten ded 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, pr osthesis 
driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, 
passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone 
skid, staple driver , bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.  
N.4580  Sonic surgical instrument and 
accessories/attachments  2 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 accessories  1 A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction 
accessories, such as cords, pulleys, or weig hts, 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 component is a device intended for medical purposes to protect or support a cast. This generic type of device 
includes the cast heel, toe cap, cast support, and walking iron.  
N.5960  Cast removal instrument  1 A cast removal instrument is an AC -powered, hand -held device intended to remove a cast from a patient. This 
gener ic type of device includes the electric cast cutter and cast vacuum.  206/222 
 N.5980  Manual cast  application and removal 
instrument  1 A manual cast application and removal instrument is a nonpowered hand -held device intended to be used in 
applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster 
dispenser, and casting stand.  
N.9999  Others(Orthopedic Devices)  1,2,3  The products excluded from the above -classification are adopted in this classification and  specified by the central 
competent health authority.  
O.0001  Static electric therapy 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 cons tipation. 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 informati on 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 des igned range of motions 
without applying f orce. This device aids patients , who suffer joint replacement surgery or with  neurological 
disease, to increase the range of joint motion.  
O.1175  Electrode ca ble 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 diagno stic 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 diagn osis 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 into muscle 
or nerve tissue to sense bioelectrical sig nals. 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.  207/222 
 O.1575  Force -measuring platform  1 A force -measuring platform is a device intended for medical purposes that converts pressure applied upon a planar 
surface into analog mechanical or  electrical signals. This device is used to determine ground 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 stimulator is a device used mainly with an elec tromyograph 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 orth otic 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 
pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical 
pylon, a transverse rotator, and a temporary training splint.  
O.3075  Cane  1 A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. 
Examples of 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 purpo ses that is used to assist a disabled 
person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples 
of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting 
position to a standing position 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 with a motorized positioning control that is  intended for medical purposes 
and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis 
(involuntary spasms) and to alter postural positions.  
O.3150  Crutch  1 A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate 
weight support while walking.  208/222 
 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 seat 
to lessen the likelihood of skin ulcers.  
O.3410  External limb orthotic component  1 An external limb orthotic component is a device intended for med ical 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 stir rup. 
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 prosthesis. 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 prosthesi s 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 prescription 
device intended for medical pu rposes, 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 total upper extre mity 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 exoskeleton is a pre scription 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 suppor t 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 s plints.  
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 assembled lower limb prostheses are the 
following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.  209/222 
 O.3520  Plinth  1 A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device 
for treat ment or examination.  
O.3610  Rigid pneumatic structure 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 use 
by pat ients 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 b y 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 ba ttery-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 us e in mechanical wheelchairs  210/222 
 O.3880  Special grade wheelchair  2 A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to 
persons 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 device incorporates an external manually controlled mechanical system that is 
intended to raise a paraplegic to an upright position by means of an elevating seat.  
O.3930  Mobile wheelchair elevator  1,2 A wheelchair elevator is a motorized lift device intended for  medical purposes .(a) 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 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.5100  Immersion hydrobath  2 An immersion hydrobath is a device intended for medical purposes that 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 tissue, and it ser ves 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 pat ient'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 external hydrothe rapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized 
tissues of the perianal and perineal areas.  
O.5150  Powered patient transport  1,2 (a)A powered patient transport is a motorized device intended for medical purposes to assist transfers of patients 
to and from the bath, beds, chairs, treatment modalities, transport vehicles, and up and down flights of stairs. This 
generic type of device does not include motorized threewheeled vehicles or wheelchairs. Classification:Cla ss 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 standar ds). 211/222 
 O.5160  Air-fluidized bed  1 An air -fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round 
ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or exte nsive 
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 moving 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 turn s 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  Microw ave 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 pai n, 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 malignancie s 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 tiss ues as described in paragraph (a) of this section.  
(2)Classification: Class 3.  212/222 
 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 u se 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 megahertz and that is intended to generate deep heat wi thin 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)Identifi cation: A shortwave diathermy for all other uses except for 
the treatment of malignancies is a device that applies to the body electromagnetic energy in the radio frequency 
bands of 13 megahertz to 27.12 megahertz and that is intended for the treatment of medical conditions by means 
other 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 body ultrasonic energy at a frequency beyond 20 k ilohertz 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 frequency beyond 20 
kilohertz and that is intend ed 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 co nsist 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 sphygmoma nometer, 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.  213/222 
 O.5525  Iontophoresis device  2 (a) Iontophoresis device intended for certain specified uses - Identification: An iontophoresis device is intended 
for use in the diagnosis of cystic fibrosis or is used along with certain drugs to achieve sp ecific 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 
device  2 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 medical purposes that consists of a compact fab ric 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 i ntended for medical purposes that consists of silica gel in a fabric container used to 
retain an elevated temperature and that provides moist heat therapy for body surfaces.  
O.5740  Powered heating pad  1 A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for 
body surfaces. It is capable of maintaining an elevated temperature during use.  
O.5760  Nonpowered lower extremity pressure 
wrap  1 A nonpowered lower extremity pressure wrap is a prescription  device that applies mechanical pressure by wrapping 
around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.  
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.  214/222 
 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  Ultra sound 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 therapeutic deep heat for selected 
medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 
20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical 
conditions such as relief of p ain, 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.  
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 dev ice intended for medical purposes to be used with powered 
traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device 
includes the pulley, strap, head halter, and pelvic belt.  
O.9999  Others(Physical Medicine Devices)  1,2,3  The products excluded from the above -classification are adopted in this classification and specified by the central 
competent health authority.  
P.0002  Blood irradiator to prevent graft versus 
host disease  2 An ionizing radiation bl ood irradiator is a device that generates ionizing radiation to irradiate blood and blood 
products (blood packs), making the lymphoid cells in the blood deactivate for the prevention of graft versus host 
disease (GVHD).  
P.1000  Magnetic resonance diagnosti c device  2 A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the 
spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting 
nuclear 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 gene ric type of device may include signal analysis and display 
equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.  215/222 
 P.1110  Positron camera  1 A positron camera is a device intended to image the distribut ion of positron -emitting radionuclides in the body. 
This generic type of device may include signal analysis and display equipment, patient and equipment supports, 
radionuclide anatomical markers, component parts, and accessories.  
P.1130  Nuclear whole body  counter  1 A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This 
generic type of device may include signal analysis and display equipment, patient and equipment supports, 
component parts, and acce ssories.  
P.1170  Bone densitometer  2 A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x -
ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of devic e 
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 transmitting 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 thro ugh 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 fluor escent 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 equipme nt 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 a nalysis and display equipment, patient and equipment supports, radionuclide 
anatomical markers, component parts, and accessories.  216/222 
 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 inclu de 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 n uclear 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 -labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests 
(testing process of exchan ge 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 calibrat ion 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 -freque ncy sound wave into body tissue 
other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in 
the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of devi ce 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 tissue 
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 d evice intended to project a pulsed sound beam into body tissue to 
determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the 
transmitter to the 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.  217/222 
 P.1570  Diagnostic ultrasonic transducer  2 A diagnostic ultrasonic transducer is a device made of a piezoelectric material t hat 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 cou pling 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, or 
lymphatic system during or after injection of a contrast medium. This generic type of device may include signal 
analysis and display equipment, patient and equipment supports, component parts, and accessories.  
P.1610  Diagnostic x -ray beam -limiting 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 came ra 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 dev ice 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 identifi cation 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 include signal analysis and display equipment, patient and equipment supports, component parts, and 
accessories.  
P.1660  Non-image -intensified fluoroscopic x -
ray system  2 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 inten ded 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.  218/222 
 P.1700  Diagnostic x -ray high voltage generator  1 A diag nostic 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 di rect 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 generic 
type 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 sys tem is a device intended to produce planar digital x -ray images of the entire 
breast. This generic type of device may include digital mammography acquisition software, full -field digital image 
receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, 
patient and equipment supports, component parts, and accessories.  
Classification. Class II  
P.1720  Mobile x -ray system  2 A mobile x -ray system is a transportable device system intended to be used to generate an d control x -ray for 
diagnostic 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 diagnost ic 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).  219/222 
 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  Radiogra phic film cassette  2 A radiographic film cassette is a device intended for use during diagnostic x -ray procedures to hold a radiographic 
film in close contact with an x -ray intensifying screen and to provide a light -proof enclosure for direct exposure 
of radiographic film.  
P.1860  Radiographic film/cassette 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 
programmer  2 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 r adiographic 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 radiographi c 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 tocoordi natean x -ray film exposure 
with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or 
respiratory cycle.  
P.1980  Radiographic table  1 A radiologic table is a device intended for medical purposes to support a p atient 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 abnormaliti es. 
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 mem ory. 220/222 
 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 de vices.  
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 co mponents 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 r elated to image manipulation, enhancement, compression or quantification.  
P.5050  Medical charged -particle radiation 
therapy system  2 A medical charged -particle radiation therapy system is a device that produces by acceleration high energy charged 
particle s (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 equipment 
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 
applic ator system  2 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 generic 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 attenuating 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, infla table, 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.  221/222 
 P.5725  Absorbable perirectal spacer  2 An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal 
wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose 
delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate 
radiotherapy treatment and is completely 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 inte nded 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 assembly  2 A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to 
support a patient during radiatio n 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 i ntended 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 a nalysis 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 -rays used for radiation therapy. 
This generic type of device may include signal analysis and display equipment, patient and equipment supports, 
treatment planning computer programs, component parts, and accessories.  
P.5930  Therapeutic x -ray tube housing a ssembly  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.  222/222 
 P.6500  Personnel protective shield  1 A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other 
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 produ cts excluded from the above -classification are adopted in this classification and specified by the central 
competent health authority.