Air Float Static Air Seat Cushion - Air Float Static Air Seat Cushion (17"x17"x1.5") - PRIMO INC

Duns Number:958758146

Device Description: Air Float Static Air Seat Cushion (17"x17"x1.5")

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More Product Details

Catalog Number

AF171715

Brand Name

Air Float Static Air Seat Cushion

Version/Model Number

AF171715

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2021

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

ae6b1283-3daf-443e-8faa-9f03d4de5360

Public Version Date

July 27, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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