McKesson - Premium Liquid Urine Controls DROPPER STYLE - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Premium Liquid Urine Controls DROPPER STYLE

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

163-89116

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

ad284af5-b4a6-4b21-9f72-01c47595dfdf

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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