Catalog Number

-

Brand Name

APEX

Version/Model Number

Pro-care Optima Prone Pump and Mattress

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

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Public Device Record Key

99be4599-83cc-4414-8cb2-6346a16de7db

Public Version Date

April 22, 2021

Public Version Number

1

DI Record Publish Date

April 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-