Catalog Number

3K-01-250034

Brand Name

metene Enhance Blood Glucose Monitoring System

Version/Model Number

3K-01-250034

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

K182428,K182428

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

6e2b255a-e23e-4c0e-942f-854e7d645204

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

04711200722833

Quantity per Package

40

Contains DI Package

00850009854032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT