Catalog Number

11460-010T

Brand Name

CARDINAL HEALTH

Version/Model Number

11460-010T

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MPO

Product Code Name

Infant heel warmer (chemical heat pack)

Public Device Record Key

15162c59-bddd-4079-a38d-9c9114daa598

Public Version Date

January 28, 2019

Public Version Number

1

DI Record Publish Date

December 28, 2018

Package DI Number

20630140017398

Quantity per Package

1

Contains DI Package

10630140017391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX