Catalog Number

CH1440-01

Brand Name

CARDINAL HEALTH

Version/Model Number

CH1440-01

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

Yes

FDA Premarket Submission

-

Product Code

JJW

Product Code Name

Urinalysis controls (assayed and unassayed)

Public Device Record Key

8435d8ed-7e8f-45df-ba0d-208be4311e59

Public Version Date

May 13, 2019

Public Version Number

1

DI Record Publish Date

May 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-