Catalog Number

516500CE

Brand Name

CARDINAL HEALTH

Version/Model Number

516500CE

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

-

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

80c43614-c0e4-4f48-aad9-f5f50e60c073

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

July 22, 2016

Package DI Number

50630140034501

Quantity per Package

4

Contains DI Package

10630140034503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE