Catalog Number

20-4043H

Brand Name

CARDINAL HEALTH

Version/Model Number

20-4043H

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

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

PXK

Product Code Name

Vascular access port kit

Public Device Record Key

9ed2063b-5acb-4d81-bc1b-f43cee99f91d

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

June 06, 2022

Package DI Number

50195594684479

Quantity per Package

30

Contains DI Package

10195594684471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE