Lesson 7 – Coding Medical Device, In-Vitro Diagnostic and Non-Medical Radiation Emitting Products
Lesson Menu
Medical Device and In-Vitro Diagnostic ProductsMedical Device and In-Vitro Diagnostic Products - Industry Codes 73-91
GlossaryThe product codes for medical device and in-vitro diagnostic products are found in a Department of Health and Human Services publication entitled "Classification Names for Medical Devices and In-Vitro Diagnostic Products." The codes are the responsibility of the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). These codes are part of the OASIS database that is used by the Product Code Builder application.
Each product name is identified by a product code that consists of five digits (2 numeric, 3 alpha). The first two digits indicate the medical specialty under which the device or diagnostic product was originally classified. Click on the scroll box to see a list of the medical specialties and their Industry Codes.
Below is a brief definition of the industry code terms.
Anesthesiology: the branch of medical science that studies and applies anesthetics. Anesthetics are drugs that cause temporary loss of bodily sensations with or without loss of consciousness.
Cardiovascular: of, relating to, or involving the heart and the blood vessels
Chemistry: the science of the composition, structure, properties, and reactions of matter, especially of atomic and molecular systems.
Dental: of or pertaining to the teeth or to dentistry; as, dental surgery.
Ear, Nose and Throat: the branch of medicine that deals with diagnosis and treatment of diseases of the ear, nose, and throat.
Gastroenterology and Urology: Gastroenterology is the branch of medicine that deals with the study of disorders affecting the stomach, intestines, and associated organs. Urology is the branch of medicine that deals with the diagnosis and treatment of diseases of the urinary tract and urogenital system.
General and Plastic Surgery: General Surgery is the branch of medicine that deals with the diagnosis and treatment of injury, deformity, and disease by manual and instrumental means. Plastic Surgery is surgery to remodel, repair, or restore body parts, especially by the transfer of tissue.
General Hospital: refers to general products not ascribed to a particular medical specialty used in a hospital or physician's office such as examination gloves, disinfectants, tongue depressors, etc.
Hematology: the science encompassing the medical study of the blood and blood-producing organs.
Immunology: the branch of medical science that studies the body's immune system
Microbiology: the branch of biology that deals with microorganisms and their effects on other living organisms.
Neurology: the medical science that deals with the nervous system and disorders affecting it.
Obstetrics and Gynecology: Obstetrics is the branch of medicine that deals with the care of women during pregnancy, childbirth, and the recuperative period following delivery. Gynecology is the branch of medicine dealing with the administration of health care to women, especially the diagnosis and treatment of disorders affecting the female reproductive organs.
Ophthalmic: of or relating to the eye
Orthopedics: the branch of medicine that deals with the prevention or correction of injuries or disorders of the skeletal system and associated muscles, joints, and ligaments.
Pathology: the scientific study of the nature of disease and its causes, processes, development, and consequences.
Physical Medicine: the branch of medicine that deals with the treatment, prevention, and diagnosis of disease by essentially physical means, including manipulation, massage, and exercise, often with mechanical devices, and the application of heat, cold, electricity, radiation, and water.
Radiology: the branch of medicine that deals with the use of radioactive substances in diagnosis and treatment of disease.
Toxicology: the study of the nature, effects, and detection of poisons and the treatment of poisoning.
Back to Medical Device and In-Vitro Diagnostic Products Index
Subclasses are not used for Medical Device and In-Vitro Diagnostic products. Although Subclass is not used in this Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
Back to Medical Device and In-Vitro Diagnostic Products Index
PICs are not used for Medical Device and In-Vitro Diagnostic products. Although Process Indicator Code is not used in this Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
Back to Medical Device and In-Vitro Diagnostic Products Index
1. The Process Indicator Code for medical device and in-vitro diagnostic products provides the following information:
2. The Subclass for medical device and in-vitro diagnostic products provides the following information:
3. Since the Subclass and Process Indicator Code components are not used for medical device and in-vitro diagnostic products how should these fields be completed by filers:
4. Why is it easier to determine the product code for a medical device or in-vitro diagnostic product by searching for a product name rather than sequentially building each component?
Back to Medical Device and In-Vitro Diagnostic Products Index
Now you will have a chance to practice coding some Medical Device and In-Vitro Diagnostic Products. Below you will find eight product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.
Have notepaper and a pen or pencil handy. As you code each product, jot down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application, it will take you to the beginning of the Tutorial.
1. LATEX EXAMINATION GLOVES (reveal code)
2. ULTRASONIC FETAL MONITOR (reveal code)
3. SUNGLASSES (reveal code)
4. ANTIBIOTIC ASSAY CULTURE MEDIA (reveal code)
5. SOFT CONTACT LENSES (EXTENDED WEAR) (reveal code)
6. ELECTRONIC THERMOMETER (reveal code)
7. TYPHUS FEVER ANTISERUM (reveal code)
8. FIRST AID KITS (reveal code)
Check your answers - Click on reveal code for each product description to reveal the correct product code. Compare it with the one you got. Did you get the correct code? If not, determine which element was incorrect. You can go back the product code builder application and try again.
Back to Medical Device and In-Vitro Diagnostic Products Index
Non-Medical Radiation Emitting Products - Industry Codes 94-97
The product codes for Non-Medical Radiation Emitting products are similar to those for Medical Devices and In-Vitro Diagnostic Products. The only difference is that the last two elements are numbers instead of letters. The codes are the responsibility of the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). These codes are part of the OASIS database that is used by the Product Code Builder application.
Industry Codes 94, 95, 96 and 97 cover twenty-five products. The first letter of the classification code assigned by CDRH goes under Product Class. However, this does not give the Product Class any specific meaning. The last two letters of the classification go under Product. Subclass and PIC codes are not used for these products, hyphens are entered in those two fields.
When you code these products, try searching for a keyword associated with the product. Often, this will quickly lead you to the Product Code.
There are four Industry Codes for these products. They include:
Ionizing Non-Medical Devices and Components Industry Code 94
Examples: Accelerator for non-medical use, High voltage vacuum tube, circuit breaker - automatic, television receiver or product containing a TV receiver
Light Emitting Non-Medical Device Products – Industry Code 95
Examples: Laser product for non-medical use, laser printers, CD players, Sunlamp for non-medical use
Radio Frequency Emitting Products – Industry Code 96
Examples: Microwave heating products, microwave ovens
Sound Emitting Products – Industry Code 97
Examples: Ultrasound product for non-medical use, cordless phones
Back to Non-Medical Radiation Emitting Products Index
Subclasses are not used for Non-Medical Radiation Emitting products. Although Subclass is not used in this Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
Back to Non-Medical Radiation Emitting Products Index
PICs are not used for Non-Medical Radiation Emitting products. Although Process Indicator Code is not used in this Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
Back to Non-Medical Radiation Emitting Products Index
Product Codes and Product Description
The following is the full list of products in Industry Codes 94, 95, 96, and 97.
|
PRODUCT CODE |
PRODUCT DESCRIPTION |
94 A - - 11 |
Accelerator for Non-medical use |
94 C - - 08 |
Cold-Cathode Gas Discharge Tube for Non-medical Use |
94 H - - 04 |
High Voltage Vacuum Tube |
94 H - - 06 |
High Voltage Vacuum Switch |
94 I - - 13 |
Industrial X-Ray System (Except Cabinet) |
94 I - - 17 |
Cabinet X-Ray System |
94 N - - 14 |
Analytical X-Ray System or Component for Non-medical Use |
94 V - - 01 |
Boards, Printed Circuit |
94 V - - 02 |
Circuit Breaker, Automatic |
94 V - - 05 |
Cathode Ray Tube |
94 V - - 07 |
Television Receiver or Product Containing a TV Receiver (includes computer monitors/video display terminals) |
95 L - - 22 |
Laser Product for Non-medical Use |
95 L - - 29 |
Laser Light Show |
95 L - - 30 |
Laser Printers |
95 L - - 31 |
CD Players (compact disc players) |
95 L - - 32 |
CD Player Combination Systems |
95 U - - 19 |
Sunlamp Product (pre standard) for Non-medical Use |
95 U - - 20 |
Ultraviolet Product (Miscellaneous) for Non-Medical Use |
95 U - - 28 |
Mercury Vapor Lamp for Non-Medical Use |
96 H - - 02 |
Microwave Heating Product (Except Oven for Food Preparation) for Non-Medical Use |
96 H - - 27 |
Industrial Dielectric Heater |
96 M - - 01 |
Microwave Oven for Food Preparation |
97 U - - 09 |
Ultrasound Product for Non-Medical Use |
97 Y - - 35 |
Sounds Product (other than Ultrasound) for Non-Medical Use |
97 Y - - 36 |
Cordless Phones |
Back to Non-Medical Radiation Emitting Products Index
1. Which of the following products would require a FDA Product Code?
2. Which of the following products would require a FDA Product Code?
3. Which of the following products would not require a FDA Product Code?
Back to Non-Medical Radiation Emitting Products Index
Now you will have a chance to practice coding some Medical Device and In-Vitro Diagnostic Products. Below you will find eight product descriptions. Read the descriptions and then click on the PCB Application button below. This will take you to the Product Code Builder application.
Have notepaper and a pen or pencil handy. As you code each product, jot down the product code result. When you're ready to check your answers, click the Tutorial button on the Taskbar. The Taskbar is located at the bottom of the screen. This will bring you back here. Caution: Don't click the Tutorial button in the Product Code Builder application, it will take you to the beginning of the Tutorial.
1. MERCURY VAPOR LAMP (NON-MEDICAL) (reveal code)
2. INDUSTRIAL DIELECTRIC HEATER (reveal code)
3. HIGH VOLTAGE VACUUM SWITCH (reveal code)
4. MICROWAVE OVEN (reveal code)
5. LASER PRINTER (reveal code)
6. TELEVISION RECEIVER (reveal code)
7. PORTABLE CD PLAYER (reveal code)
Check your answers - Click on reveal code for each product description to reveal the correct product code. Compare it with the one you got. Did you get the correct code? If not, determine which element was incorrect. You can go back the product code builder application and try again.