Identity
- Trade Name
- OneTouch Ultra2 FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip FDA UDI
- Model / Reference
- 021-100 FDA UDI
- Description
- OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip FDA UDI
Identifiers
- Catalog Number
- 021-100 FDA UDI
- Primary DI / UDI-DI
- 00353885008853 FDA UDI
- 510(k) Number
- K053529 FDA UDI
- FDA Product Code
- CGA FDA UDINBW 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
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
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDI
Category: Glucose monitoring system IVD, home-useGlucose IVD, kit, electrometryBlood lancing device tipManual blood lancing device, reusable
OneTouch Ultra2 by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
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- Autolet — OWEN MUMFORD USA INCORPORATED · Class II
- Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- TeleRPM & Chronica — Mio Labs Inc.
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
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 245f3a44-cc25-49bf-90ac-278bde9d77e8 38 fields · synced Jun 8, 2026