McKesson - URINE TEST STRIP, 4LN F/121-12 - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: URINE TEST STRIP, 4LN F/121-12

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-4LN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

CDM

Product Code Name

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

Device Record Status

Public Device Record Key

23826cb4-f54b-4cc4-ba3b-65466fcf6547

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

20612479183500

Quantity per Package

1

Contains DI Package

10612479183497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MCKESSON MEDICAL-SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 870
2 A medical device with a moderate to high risk that requires special controls. 422
U Unclassified 44