Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-10SG

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

K142543,K142543,K142543,K142543

Product Code

CDM

Product Code Name

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Public Device Record Key

d2c2321d-aff6-4783-b43e-813419c6bcfd

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

20612479183531

Quantity per Package

1

Contains DI Package

10612479183527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box