True Metrix

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name: TRUE METRIX FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM Starter Kit - FOR HUMANA FDA UDI
Model / Reference: TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM FDA UDI
Description: TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM Starter Kit - FOR HUMANA FDA UDI

Identifiers

Catalog Number: RE4081-03 FDA UDI
Primary DI / UDI-DI: 00021292014797 FDA UDI
FDA Product Code: LFR FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

True Metrix by Trividia Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Trividia Health, Inc.

Sources (1)

FDA UDI 2324004f-75a7-44e3-b8c1-451a5b5d4c67 36 fields · synced Jun 8, 2026