AirFloat Static Air Seat Cushion - AirFloat Static Air Seat Cushion (17"x17") with - PRIMO INC

Duns Number:958758146

Device Description: AirFloat Static Air Seat Cushion (17"x17") with pump

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More Product Details

Catalog Number

AF1717P

Brand Name

AirFloat Static Air Seat Cushion

Version/Model Number

AF1717P

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

6a0c3249-9d48-4a06-815a-b4942307e29a

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

10810006683537

Quantity per Package

12

Contains DI Package

00810006683530

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