Catalog Number

-

Brand Name

Bariatric Air Cushions

Version/Model Number

10671

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"

Yes

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

KIC

Product Code Name

Cushion, Flotation

Public Device Record Key

ccf67b6c-cd11-440d-8df5-ffab67d70824

Public Version Date

July 19, 2022

Public Version Number

3

DI Record Publish Date

April 22, 2021

Package DI Number

00616784067148

Quantity per Package

6

Contains DI Package

00616784067117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper