Catalog Number

30635-611

Brand Name

CARDINAL HEALTH

Version/Model Number

30635-611

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

8d09c184-f7d4-471f-96b7-92ba75480377

Public Version Date

July 05, 2019

Public Version Number

1

DI Record Publish Date

June 27, 2019

Package DI Number

50630140015685

Quantity per Package

50

Contains DI Package

00630140015680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE