Duns Number:867673159
Device Description: Pressure PreventionSeat and Back Cushions Product Description: Premier One FoamBackCushion Pressure PreventionSeat and Back Cushions Product Description: Premier One FoamBackCushion 22x19 ,1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
8033
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
KIC
Product Code Name
CUSHION, FLOTATION
Public Device Record Key
0ad5464e-4387-4fa2-9a50-d31426e4da66
Public Version Date
July 15, 2019
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
50822383514524
Quantity per Package
6
Contains DI Package
00822383514529
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |