Catalog Number

P5191-4

Brand Name

CARDINAL HEALTH

Version/Model Number

P5191-4

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"

-

For Single-Use

Yes

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

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

26f40560-a5b4-40a0-bca5-a39874493a24

Public Version Date

July 22, 2021

Public Version Number

6

DI Record Publish Date

August 15, 2016

Package DI Number

50885380117525

Quantity per Package

40

Contains DI Package

30885380117521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE