True Focus

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name: TRUE FOCUS FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: TRUE FOCUS Self Monitoring Test Strip - 50ct FDA UDI
Model / Reference: TRUE FOCUS Self Monitoring Test Strip - 50ct FDA UDI
Description: TRUE FOCUS Self Monitoring Test Strip - 50ct FDA UDI

Identifiers

Primary DI / UDI-DI: 00021292008956 FDA UDI
510(k) Number: K131013 FDA UDI
FDA Product Code: LFR FDA UDI
NBW FDA UDI
JJX 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
862.1660 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

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

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

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LEADER — Cardinal Health 110, Inc. · Class II
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Oh'Care Lite — IJDREAM CORPORATION · Class I

Cleared under the same submission

K131013 also covers:

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 20358578-208f-4890-b60c-bc354f1d8f73 36 fields · synced Jun 8, 2026