Catalog Number

19-3766B

Brand Name

CARDINAL HEALTH

Version/Model Number

19-3766B

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FKG

Product Code Name

TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Public Device Record Key

89c9bdfb-a7ae-4051-bd05-bc9f7850388f

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

50887488908586

Quantity per Package

24

Contains DI Package

10887488908588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE