Catalog Number

-

Brand Name

My-TECH

Version/Model Number

My-TECH Self Monitoring Blood Glucose Test Strips

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

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

2c694492-19be-40ef-958d-c256e513d3ad

Public Version Date

August 16, 2019

Public Version Number

1

DI Record Publish Date

August 08, 2019

Package DI Number

10021292013117

Quantity per Package

12

Contains DI Package

00021292013110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case