TRUE METRIX GO RF4H01-40

GUDID 10021292009790

TRUE METRIX GO Self Monitoring Blood Glucose Meter - Not For Retail Sale - Meter Only

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID10021292009790
NIH Device Record Keycd64d982-365a-46a8-bd23-fcc52543909c
Commercial Distribution Discontinuation2021-05-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTRUE METRIX GO
Version Model NumberTRUE METRIX GO Self Monitoring Blood Glucose Meter
Catalog NumberRF4H01-40
Company DUNS151810868
Company NameTRIVIDIA HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100021292007706 [Direct Marking]
GS100021292009793 [Primary]
GS110021292009790 [Package]
Contains: 00021292009793
Package: CASE [40 Units]
Discontinued: 2021-05-27
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-19
Device Publish Date2017-04-13

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