Catalog Number

-

Brand Name

TRUEread

Version/Model Number

TRUEread 50 Blood Glucose Test Strips

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2017

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

K042080,K042080,K042080,K042080,K042080,K042080,K042080,K042080,K042080

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

7ce09f91-118c-4e1e-b166-0b1044242813

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10087701403511

Quantity per Package

24

Contains DI Package

00087701403514

Package Discontinue Date

October 12, 2017

Package Status

Not in Commercial Distribution

Package Type

Case