DRIVEMEDICAL - Rollators4-Wheel Alum Product Description: Airgo - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: Rollators4-Wheel Alum Product Description: Airgo eXcursion Reg 20", Purple,1EA

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More Product Details

Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

700-920PR

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITJ

Product Code Name

WALKER, MECHANICAL

Device Record Status

Public Device Record Key

7f32a377-c13e-4dc3-9c1f-60f3fb49c2d7

Public Version Date

June 10, 2022

Public Version Number

3

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