Catalog Number

-

Brand Name

Drive

Version/Model Number

BA9600-PUMP

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

FNM

Product Code Name

MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Public Device Record Key

4131c88c-3dda-4cf3-9c9a-1c474969bde0

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 16, 2018

Package DI Number

10822383982943

Quantity per Package

10

Contains DI Package

00822383982946

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-