Catalog Number

3K-01-140039

Brand Name

GlucoLeader Enhance Blood Glucose Monitoring System

Version/Model Number

3K-01-140039

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

K032985,K032985

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ebaf7752-4c7d-4f19-b620-94246395ca87

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

04711200723014

Quantity per Package

48

Contains DI Package

04711200720570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT