Catalog Number

-

Brand Name

Drive

Version/Model Number

14002E-220

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

4d4e0e7b-a8df-4cf4-930f-0f544b7d2340

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

December 05, 2016

Package DI Number

10822383227785

Quantity per Package

6

Contains DI Package

00822383227788

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-