Duns Number:967025602
Device Description: The Carewise 5.1 mattress features a diamond-cut top foam layer for pressure redistributi The Carewise 5.1 mattress features a diamond-cut top foam layer for pressure redistribution, shear reduction, and air circulation, keeping the surfacecool for optimal patient comfort. The high-resiliency heel area is softer than the rest of the surface to protect vulnerable heels, and the full-length base prevents bottoming out.
Catalog Number
-
Brand Name
Carewise 5.1 Mattress
Version/Model Number
5.1
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)
Yes
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
9b1fe579-3ead-4902-a733-2308e72bc129
Public Version Date
September 25, 2020
Public Version Number
1
DI Record Publish Date
September 17, 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 | 130 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |