Catalog Number

3S-01-14003Y

Brand Name

GlucoLeader Enhance Blood Glucose vial packed test strip

Version/Model Number

3S-01-14003Y

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)

-

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

a4c9240d-07e5-4470-8a71-7f224ff03e0c

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

04711200722994

Quantity per Package

400

Contains DI Package

04711200722840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX