Catalog Number

-

Brand Name

INVACARE® BED EXTENDER

Version/Model Number

5143IVC

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

LLI

Product Code Name

Bed, therapeutic, ac-powered, adjustable home-use

Public Device Record Key

658b3e9a-3b9d-4eeb-99c5-e2514386c4e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-