Catalog Number

RF4H01-40

Brand Name

TRUE METRIX GO

Version/Model Number

TRUE METRIX GO Self Monitoring Blood Glucose Meter - NFRS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2021

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)

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

cd64d982-365a-46a8-bd23-fcc52543909c

Public Version Date

July 19, 2021

Public Version Number

4

DI Record Publish Date

April 13, 2017

Package DI Number

10021292009790

Quantity per Package

40

Contains DI Package

00021292009793

Package Discontinue Date

May 27, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE