Catalog Number

14000

Brand Name

NOVO Health Services, LLC

Version/Model Number

14000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152884

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Public Device Record Key

ffbcb30c-d4cd-489d-b549-e334e95c34d4

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

January 11, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-