Catalog Number

11443-012

Brand Name

CARDINAL HEALTH

Version/Model Number

11443-012

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

b4882d39-a2eb-48f5-95cb-ba604853eb7b

Public Version Date

January 28, 2019

Public Version Number

1

DI Record Publish Date

December 28, 2018

Package DI Number

20888499004884

Quantity per Package

1

Contains DI Package

00888499004880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX