Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-BCTHLDRSF

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

-

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

K172763,K172763,K172763

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

878b7112-400b-4f03-8537-4dd7291a71b6

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

November 22, 2019

Package DI Number

40612479244458

Quantity per Package

40

Contains DI Package

20612479244447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case