UltraTRAK PRO Blood Glucose Monitoring System

FDA UDI

Class II (US FDA UDI)

by Vertex Diagnostics Llc

Identity

Trade Name: UltraTRAK PRO Blood Glucose Monitoring System FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Model / Reference: TD-4255 FDA UDI

Identifiers

Primary DI / UDI-DI: 00385930011082 FDA UDI
510(k) Number: K082618 FDA UDI
FDA Product Code: 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

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

UltraTRAK PRO Blood Glucose Monitoring System by Vertex Diagnostics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Gmate® Origin Blood Glucose Monitoring System — Philosys, Inc. · Class II
One Drop — INFORMED DATA SYSTEMS INC. · Class II
TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
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

Cleared under the same submission

K082618 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

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

Manufacturer

Manufacturer: Vertex Diagnostics Llc

Sources (1)

FDA UDI 5b2ff095-5b16-48d3-8053-a6a07c6993fb 33 fields · synced May 30, 2026