Catalog Number

UE4001-00

Brand Name

TRUE FOCUS

Version/Model Number

TRUE FOCUS Self Monitoring Blood Glucose Meter

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

-

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

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

4de9114c-3c1f-460b-9bb4-56019aa89b43

Public Version Date

November 12, 2018

Public Version Number

4

DI Record Publish Date

June 21, 2017

Package DI Number

10311917188062

Quantity per Package

12

Contains DI Package

00311917188065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE