Catalog Number

3K-01-140108

Brand Name

GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)

Version/Model Number

3K-01-140108

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

8337a70e-aca2-4f58-a201-4b1fa2214703

Public Version Date

May 29, 2020

Public Version Number

2

DI Record Publish Date

May 11, 2020

Package DI Number

00389154000891

Quantity per Package

216

Contains DI Package

04711200722246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT