Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-011

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142543,K142543,K142543

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

c7cc87bf-f7db-4a62-9985-fac07366d8fc

Public Version Date

March 26, 2019

Public Version Number

1

DI Record Publish Date

March 18, 2019

Package DI Number

00612479197428

Quantity per Package

10

Contains DI Package

00612479197411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case