Catalog Number

3987156

Brand Name

CARDINAL HEALTH

Version/Model Number

3987156

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DSF

Product Code Name

RECORDER, PAPER CHART

Public Device Record Key

4994bad3-4866-48b4-9d69-c205a22b470a

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Package DI Number

50885380112391

Quantity per Package

20

Contains DI Package

30885380112397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE