Catalog Number

-

Brand Name

co-innovation

Version/Model Number

ETG-Dipcard

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 19, 2018

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

DJZ

Product Code Name

Devices, Breath Trapping, Alcohol

Public Device Record Key

bea20463-d069-4cfc-a4ba-704bef7d0df3

Public Version Date

December 20, 2018

Public Version Number

1

DI Record Publish Date

November 19, 2018

Package DI Number

16970429840635

Quantity per Package

100

Contains DI Package

06970429840638

Package Discontinue Date

November 19, 2018

Package Status

Not in Commercial Distribution

Package Type

-