Catalog Number

-

Brand Name

NA

Version/Model Number

S2002-3061

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2018

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

8481def0-7bb2-4188-a7b7-9a8da4e10e58

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

March 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-