Drive - PowerPower Front Wheel Product Description: Titan - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: PowerPower Front Wheel Product Description: Titan with AuditGuard

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More Product Details

Catalog Number

-

Brand Name

Drive

Version/Model Number

AG-TITAN20CSX16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

INI

Product Code Name

VEHICLE, MOTORIZED 3-WHEELED

Device Record Status

Public Device Record Key

4f8c06a4-02d2-4bd7-bf9c-7c6c7d8c2bb1

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRIVE DEVILBISS HEALTHCARE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3783
2 A medical device with a moderate to high risk that requires special controls. 832