Catalog Number

RF4H01-01BK

Brand Name

TRUE METRIX GO

Version/Model Number

TRUE METRIX GO 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)

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

e1509d0b-fee9-4952-9a86-4336f3cfd662

Public Version Date

November 12, 2018

Public Version Number

3

DI Record Publish Date

April 13, 2017

Package DI Number

10021292006119

Quantity per Package

12

Contains DI Package

00021292006112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE