Others titles
- Product Code Classification Database
- Device Classification Product Code
Keywords
- Medical Devices Classification
- Device Classification Panels
- Product Code
- Medical Devices Classification Database
- Product Devices Code Identify
Medical Devices Classification

The Medical Devices classification Database dataset contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission.
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Description
The Medical Devices Classification dataset contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
The three classes and the requirements which apply to them are:
1. Class I General Controls: With Exemptions or Without Exemptions.
2. Class II General Controls and Special Controls: With Exemptions or Without Exemptions.
3. Class III General Controls and Premarket Approval
About this Dataset
Data Info
Date Created | 2014-06 |
---|---|
Last Modified | 2023-09-24 |
Version | 2023-09-24 |
Update Frequency |
Weekly |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Medical Devices Classification, Device Classification Panels, Product Code, Medical Devices Classification Database, Product Devices Code Identify |
Other Titles | Product Code Classification Database, Device Classification Product Code |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Review_Panel | Review Panel | string | maxLength : 2 |
Medical_Specialty | Medical specialty panel responsible for reviewing the product | string | maxLength : 2 |
Product_Code | Product Code | string | required : 1maxLength : 3 |
Device_Name | Device Category Name | string | required : 1 |
Device_Class | string | required : 1enum : Array ( [0] => 1 [1] => 2 [2] => 3 [3] => f [4] => N [5] => U ) maxLength : 1 | |
Unclassified_Reason | Unclassified Reason Code | string | maxLength : 2 |
Is_GMP_Exempt_Flag | GMP Exempt Flag | boolean | required : 1 |
Is_Third_Party_Flag | Third Party Review Eligible | boolean | - |
Regulation_Number | Regulation number of classification regulation which identifies this device | string | - |
Submission_Type_ID | Submission Type ID | number | level : Nominal |
Definition | Definition | string | - |
Physical_State | Physical state of product | string | - |
Technical_Method | Technical method | string | - |
Target_Area | Target area in body | string | - |
Is_Implant_Flag | Implant product | boolean | - |
Is_Life_Sustain_Support_Flag | Life Sustain product | boolean | - |
Summary_Malfunction_Reporting | Indicate if device is elegible for summary malfunction reporting or not. | string | enum : Array ( [0] => Eligible [1] => Ineligible ) |
Data Preview
Review Panel | Medical Specialty | Product Code | Device Name | Device Class | Unclassified Reason | Is GMP Exempt Flag | Is Third Party Flag | Regulation Number | Submission Type ID | Definition | Physical State | Technical Method | Target Area | Is Implant Flag | Is Life Sustain Support Flag | Summary Malfunction Reporting |
AN | AN | BRW | Protector, Dental | 1 | False | False | 868.582 | 4 | False | False | Eligible | |||||
AN | AN | BRX | Stool, Anesthesia | 1 | False | False | 868.67 | 4 | False | False | Eligible | |||||
AN | AN | BRY | Cabinet, Table And Tray, Anesthesia | 1 | False | False | 868.61 | 4 | False | False | Eligible | |||||
AN | AN | BSE | Analyzer, Gas, Helium, Gaseous-Phase | 2 | False | True | 868.164 | 1 | False | False | Eligible | |||||
AN | AN | BSF | Absorber, Carbon-Dioxide | 1 | False | False | 868.531 | 4 | False | False | Eligible | |||||
AN | AN | BSI | Algesimeter, Powered | 2 | False | False | 868.104 | 4 | False | False | Eligible | |||||
AN | AN | BSJ | Mask, Gas, Anesthetic | 1 | False | False | 868.555 | 4 | False | False | Eligible | |||||
AN | AN | BSK | Cuff, Tracheal Tube, Inflatable | 2 | False | True | 868.575 | 1 | False | True | Eligible | |||||
AN | AN | BSN | Filter, Conduction, Anesthetic | 2 | False | True | 868.513 | 1 | False | False | Eligible | |||||
AN | AN | BSO | Catheter, Conduction, Anesthetic | 2 | False | True | 868.512 | 1 | False | False | Eligible |