Catalog Number

-

Brand Name

TRUE FOCUS

Version/Model Number

TRUE FOCUS Self Monitoring Test Strip - 50ct

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

K131013,K131013,K131013,K131013

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

20358578-208f-4890-b60c-bc354f1d8f73

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 21, 2017

Package DI Number

10311917188086

Quantity per Package

24

Contains DI Package

00311917188089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE