Catalog Number

12A0134H

Brand Name

CARDINAL HEALTH

Version/Model Number

12A0134H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2018

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

OKE

Product Code Name

Port introducer kit

Public Device Record Key

9690195a-f32c-4ca0-9560-62a01e4c1968

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-