Clinicare Active Mattress w/ Micro Climate Management - SIZEWISE RENTALS, L.L.C.

Duns Number:967025602

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Clinicare Active Mattress w/ Micro Climate Management

Version/Model Number

4500-CA03584

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)

-

Kit

-

Combination Product

Yes

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

cca45a4f-9b08-4717-8e8a-3dde8b039767

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 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