Catalog Number

CHUA260

Brand Name

CARDINAL HEALTH

Version/Model Number

CHUA260

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2021

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

1a7d760c-e5ee-4b65-a108-772f7e221063

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

May 24, 2019

Package DI Number

50885380151932

Quantity per Package

4

Contains DI Package

10885380151934

Package Discontinue Date

February 17, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX