Duns Number:958758146
Device Description: Air Float Static Air Seat Cushion (17"x17"x1.5")
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
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
FMP
Product Code Name
Protector, Skin Pressure
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 208 |