Carewise 5.1 Mattress - The Carewise 5.1 mattress features a diamond-cut - SIZEWISE RENTALS, L.L.C.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIZEWISE RENTALS, L.L.C." Characteristics
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