← Back to catalogue

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
GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY FDA UDI
Model / Reference
TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY FDA UDI
Description
GOOD NEIGHBOR PHARMACY TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY FDA UDI

Identifiers

Catalog Number
A4011-85 FDA UDI
Primary DI / UDI-DI
00087701405570 FDA UDI
510(k) Number
K032657 FDA UDI
FDA Product Code
NBW FDA UDI
JJX FDA UDI
CGA 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

No

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Trividia Health, Inc.

Sources (1)

  • FDA UDI 856840ac-9930-41e5-b015-c342969e4069 38 fields · synced Jun 8, 2026