Kurin Blood Collection Set, 21 Ga, BD Vacutainer - PATHWAY, LLC

Duns Number:080312381

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More Product Details

Catalog Number

-

Brand Name

Kurin Blood Collection Set, 21 Ga, BD Vacutainer

Version/Model Number

D-11221

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2018

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

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

e3418003-cfd9-4c44-96a3-777612826121

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

March 13, 2017

Additional Identifiers

Package DI Number

20851682007030

Quantity per Package

4

Contains DI Package

10851682007033

Package Discontinue Date

July 23, 2018

Package Status

Not in Commercial Distribution

Package Type

-

"PATHWAY, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8