Duns Number:078582655
Device Description: Protekt Aire 8500 48"x80"x10" Foam Perimeter Cavity w/Air Bladder Insert w/8000 Dual Compr Protekt Aire 8500 48"x80"x10" Foam Perimeter Cavity w/Air Bladder Insert w/8000 Dual Compressor Pump
Catalog Number
85050-48
Brand Name
Protekt Aire
Version/Model Number
85050-48
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
c9728878-0c2d-417a-8d6b-c6e81e482a76
Public Version Date
April 01, 2020
Public Version Number
1
DI Record Publish Date
March 24, 2020
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |