Duns Number:867673159
Device Description: Pressure PreventionRetail Foam Product Description: Convoluted Foam Pad 34Wx76Lx3.5H 1ea/6 Pressure PreventionRetail Foam Product Description: Convoluted Foam Pad 34Wx76Lx3.5H 1ea/6CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
M6026
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
FMW
Product Code Name
COVER, MATTRESS (MEDICAL PURPOSES)
Public Device Record Key
5fb3f862-3351-4711-b50d-5ab3c13774c1
Public Version Date
July 01, 2019
Public Version Number
1
DI Record Publish Date
June 21, 2019
Package DI Number
50822383518140
Quantity per Package
6
Contains DI Package
00822383518145
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 |