Catalog Number

5331

Brand Name

PKIT, RWF, NO PILLOW

Version/Model Number

5331-1

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"

Yes

For Single-Use

Yes

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

KME

Product Code Name

Bedding, Disposable, Medical

Public Device Record Key

9a28193a-aef7-45c8-9100-42405e535067

Public Version Date

July 16, 2021

Public Version Number

3

DI Record Publish Date

August 05, 2019

Package DI Number

10842430110846

Quantity per Package

6

Contains DI Package

00842430110849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case