TRUE METRIX RE4002-77

GUDID 50096295139551

Leader TRUE METRIX PRE-PACK 4x24

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID50096295139551
NIH Device Record Key29fc1ccb-158f-46bc-980e-22fd71d2afa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUE METRIX
Version Model NumberTRUE METRIX PRE-PACK 4x24
Catalog NumberRE4002-77
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100021292007690 [Direct Marking]
GS100021292007690 [Direct Marking]
GS100021292007690 [Direct Marking]
GS150096295139551 [Primary]
GS150096295139551 [Primary]
GS150096295139551 [Primary]

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

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