Catalog Number

5700414

Brand Name

CardioChek

Version/Model Number

5700414

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022898,K023558,K022898,K023558

Product Code

CHH

Product Code Name

ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Public Device Record Key

fb04be17-469f-4e0d-a436-1b97e3b72731

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-