Catalog Number

-

Brand Name

American Bantex

Version/Model Number

APP-1000-GBN

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

03686cb8-b342-4afe-b4b1-2487d9ac7cae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2016

Package DI Number

40092237602223

Quantity per Package

4

Contains DI Package

00092237602225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA