Catalog Number

-

Brand Name

NA

Version/Model Number

S2101-A310

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Public Device Record Key

86095dd1-c94a-4a61-9c04-b48d100a0694

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Package DI Number

04719873693382

Quantity per Package

10

Contains DI Package

04719873693375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-