Catalog Number

6400H

Brand Name

Action®

Version/Model Number

Mattress Overlay

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

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Public Device Record Key

0b529a06-9a2f-4532-82d7-d55846752329

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-