Catalog Number

-

Brand Name

co-innovation

Version/Model Number

16P CUP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153050,K153050,K153050,K153050

Product Code

DIC

Product Code Name

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Public Device Record Key

31f5f43e-66af-4ca4-b808-e60e29e40dc7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 29, 2021

Package DI Number

16970429841618

Quantity per Package

25

Contains DI Package

06970429841611

Package Discontinue Date

March 29, 2021

Package Status

Not in Commercial Distribution

Package Type

-