Air Float Static Air Mattress Overlay - Air Float Static Air Mattress Overlay Bariatric - PRIMO INC

Duns Number:958758146

Device Description: Air Float Static Air Mattress Overlay Bariatric (76"x47"'x3")

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More Product Details

Catalog Number

AF76473

Brand Name

Air Float Static Air Mattress Overlay

Version/Model Number

AF76473

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

a2fe78b6-f5c2-4047-bb85-bf83b4c60a25

Public Version Date

March 11, 2019

Public Version Number

1

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