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TRUEtrack

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name
TRUEtrack FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
RITE AID PHARMACY TRUEtrack blood glucose monitor FDA UDI
Model / Reference
TRUEtrack blood glucose monitor FDA UDI
Description
RITE AID PHARMACY TRUEtrack blood glucose monitor FDA UDI

Identifiers

Catalog Number
A4066-81 FDA UDI
Primary DI / UDI-DI
00011822577540 FDA UDI
510(k) Number
K032657 FDA UDI
FDA Product Code
NBW FDA UDI
CGA 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K032657 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trividia Health, Inc.

Sources (1)

  • FDA UDI f2dbab25-4aef-4c72-b564-64462fbc4143 37 fields · synced Jun 8, 2026