Catalog Number

BRDXPLUS

Brand Name

Invacare Birdie Evo XPlus Full Body Lift

Version/Model Number

BRDXPLUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FSA

Product Code Name

Lift, patient, non-ac-powered

Public Device Record Key

7a065b94-32f3-46f9-9460-ccb5a43767ab

Public Version Date

March 16, 2022

Public Version Number

1

DI Record Publish Date

March 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-