Medical Devices Classification

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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.

Complexity

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

Date Created

2014-06

Last Modified

2019-06-30

Version

2019-06-30

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

NameDescriptionTypeConstraints
Review_PanelReview PanelstringmaxLength : 2
Medical_SpecialtyMedical specialty panel responsible for reviewing the productstringmaxLength : 2
Product_CodeProduct Codestringrequired : 1 maxLength : 3
Device_NameDevice Category Namestringrequired : 1
Device_Classstringrequired : 1 enum : Array maxLength : 1
Unclassified_ReasonUnclassified Reason CodestringmaxLength : 2
Is_GMP_Exempt_FlagGMP Exempt Flagbooleanrequired : 1
Third_Party_FlagThird Party Review Eligiblestringrequired : 1 enum : Array maxLength : 1
Review_CodeThird Party Review Codestring-
Regulation_NumberRegulation number of classification regulation which identifies this devicestring-
Submission_Type_IDSubmission Type IDnumberlevel : Nominal
DefinitionDefinitionstring-
Physical_StatePhysical state of productstring-
Technical_MethodTechnical methodstring-
Target_AreaTarget area in bodystring-
Is_Implant_FlagImplant productboolean-
Is_Life_Sustain_Support_FlagLife Sustain productboolean-
Summary_Malfunction_ReportingIndicate if device is elegible for summary malfunction reporting or not.stringenum : Array
Review PanelMedical SpecialtyProduct CodeDevice NameDevice ClassUnclassified ReasonIs GMP Exempt FlagThird Party FlagReview CodeRegulation NumberSubmission Type IDDefinitionPhysical StateTechnical MethodTarget AreaIs Implant FlagIs Life Sustain Support FlagSummary Malfunction Reporting
ANANBRWProtector, Dental1FalseN868.5824FalseFalseEligible
ANANBRXStool, Anesthesia1FalseN868.674FalseFalseEligible
ANANBRYCabinet, Table And Tray, Anesthesia1FalseN868.614FalseFalseEligible
ANANBSEAnalyzer, Gas, Helium, Gaseous-Phase2FalseP868.1641FalseFalseEligible
ANANBSFAbsorber, Carbon-Dioxide1FalseN868.5314FalseFalseEligible
ANANBSIAlgesimeter, Powered2FalseP868.1044FalseFalseEligible
ANANBSJMask, Gas, Anesthetic1FalseN868.5554FalseFalseEligible
ANANBSKCuff, Tracheal Tube, Inflatable2FalseP868.5751FalseTrueEligible
ANANBSNFilter, Conduction, Anesthetic2FalseP868.5131FalseFalseEligible
ANANBSOCatheter, Conduction, Anesthetic2FalseP868.5121FalseFalseEligible