Catalog Number

CH3158-3

Brand Name

CARDINAL HEALTH

Version/Model Number

CH3158-3

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

-

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

GIF

Product Code Name

DILUENT, BLOOD CELL

Public Device Record Key

fb193034-08af-420d-a60b-446df98c5f96

Public Version Date

October 09, 2019

Public Version Number

2

DI Record Publish Date

April 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-