OneTouch Ultra2

FDA UDI

Class II (US FDA UDI)

by Lifescan Europe

Identity

Trade Name: OneTouch Ultra2 FDA UDI
Generic Name: Glucose analyser IVD, home-use FDA UDI
Device Name: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. FDA UDI
Model / Reference: 023-065 FDA UDI
Description: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. FDA UDI

Identifiers

Catalog Number: 023-065 FDA UDI
Primary DI / UDI-DI: 00353885010511 FDA UDI
510(k) Number: K053529 FDA UDI
FDA Product Code: NBW FDA UDI
CGA FDA UDI
GMDN Term: Glucose analyser 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose analyser IVD, home-use

OneTouch Ultra2 by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose analyser IVD, home-use.

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telli health — Bioland Technology Ltd. · Class II
iHealth — IHEALTH LAB INC. · Class II
NuvoMed — NUVOMED INC · Class II
VivaGuard Ino Smart Blood Glucose Meter — ABOUND Diagnostics, Inc · Class II
CURO A1c — KPI HEALTHCARE, INC. · Class II

Cleared under the same submission

K053529 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: Lifescan Europe

Sources (1)

FDA UDI 52f967a9-e676-4d58-9342-b7bdc66032dc 38 fields · synced May 30, 2026