McKesson - Extension Set, Bifurcated 9" w/check valve - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Extension Set, Bifurcated 9" w/check valve

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

MS409

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

K955896,K955896

Product Code Details

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

d919e68b-456b-4fad-ac9a-462476dbeb8a

Public Version Date

March 04, 2022

Public Version Number

1

DI Record Publish Date

February 24, 2022

Additional Identifiers

Package DI Number

40612479261967

Quantity per Package

50

Contains DI Package

10612479261959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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