My-TECH

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name: My-TECH FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: My-TECH Self Monitoring Blood Glucose Test Strips FDA UDI
Model / Reference: My-TECH Self Monitoring Blood Glucose Test Strips FDA UDI
Description: My-TECH Self Monitoring Blood Glucose Test Strips FDA UDI

Identifiers

Primary DI / UDI-DI: 00021292013127 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

My-TECH by Trividia Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, home-use.

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CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
LEADER — Cardinal Health 110, Inc. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II
Oh'Care Lite — IJDREAM CORPORATION · Class I

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 2c694492-19be-40ef-958d-c256e513d3ad 35 fields · synced Jun 8, 2026