OneTouch Ultra

FDA UDI

Class II (US FDA UDI)

by Lifescan, Inc.

Identity

Trade Name: OneTouch Ultra FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Model / Reference: 024-391 FDA UDI

Identifiers

Primary DI / UDI-DI: 00353885013000 FDA UDI
510(k) Number: K053529 FDA UDI
FDA Product Code: NBW FDA UDI
CGA FDA UDI
GMDN Term: Glucose IVD, kit, electrometry 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose IVD, kit, electrometry

OneTouch Ultra by Lifescan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose IVD, kit, electrometry.

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FORA — FORA CARE INC. · Class II
EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II
Prodigy No Coding Blood Glucose Test Strips — PRODIGY DIABETES CARE, LLC · 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, Inc.

Sources (1)

FDA UDI 41d38192-ce21-420b-a854-e58822952023 34 fields · synced Jun 8, 2026