OneTouch Ultra2 Blood Glucose Monitoring System.

FDA UDI

Class II (US FDA UDI)

by Lifescan Europe

Identity

Trade Name: OneTouch Ultra2 Blood Glucose Monitoring System. FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: OneTouch Ultra2 Blood Glucose Monitoring System. FDA UDI
Model / Reference: 024-047 FDA UDI
Description: OneTouch Ultra2 Blood Glucose Monitoring System. FDA UDI

Identifiers

Catalog Number: 024-047 FDA UDI
Primary DI / UDI-DI: 00353885011860 FDA UDI
FDA Product Code: NBW 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
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

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 30 Gauge FDA UDI

Category: Glucose monitoring system IVD, home-use

OneTouch Ultra2 Blood Glucose Monitoring System. by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 87fafd02-6e3f-4e6a-b463-40497834894e 37 fields · synced Jun 1, 2026