Catalog Number

-

Brand Name

Ever-Soft Alternating Pressure Air Cushion

Version/Model Number

10675

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

a3e23d37-c460-4f63-b5f0-8f2c9d9e34aa

Public Version Date

May 17, 2022

Public Version Number

1

DI Record Publish Date

May 09, 2022

Package DI Number

00616784067544

Quantity per Package

5

Contains DI Package

00616784067513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper