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

Duns Number:867673159

Device Description: PowerPower Front Wheel Product Description: Trident HD P24, 24" Pan Seat, 1/ea

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More Product Details

Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

2850HDP24-24

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2019

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

ITI

Product Code Name

Wheelchair, powered

Device Record Status

Public Device Record Key

67b34021-d802-407e-9ce5-6f93c5ef44b1

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