AirFloat Static Air Seat Cushion - AirFloat Static Air Seat Cushion Bariatric - PRIMO INC

Duns Number:958758146

Device Description: AirFloat Static Air Seat Cushion Bariatric (28"x22") with pump

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More Product Details

Catalog Number

AF2822P

Brand Name

AirFloat Static Air Seat Cushion

Version/Model Number

AF2822P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

af5be118-50c9-441d-acdb-f9790468b0a2

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

10810006684121

Quantity per Package

12

Contains DI Package

00810006684124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each

"PRIMO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208