Catalog Number

11429-015

Brand Name

CARDINAL HEALTH

Version/Model Number

11429-015

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IME

Product Code Name

Pack, hot or cold, reusable

Public Device Record Key

87e207d4-ee0c-4301-9e6a-9c2d5fdf76e8

Public Version Date

September 27, 2019

Public Version Number

2

DI Record Publish Date

December 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-