Identity
- Trade Name
- OneTouch Ultra2 FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- OneTouch Ultra2 Blood Glucose Monitoring System. FDA UDI
- Model / Reference
- 024-046 FDA UDI
- Description
- OneTouch Ultra2 Blood Glucose Monitoring System. FDA UDI
Identifiers
- Catalog Number
- 024-046 FDA UDI
- Primary DI / UDI-DI
- 00353885011853 FDA UDI
- FDA Product Code
- NBW FDA UDICGA 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
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
No
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 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 83d6edaa-3d6b-42c6-b33a-3d33892e9f57 37 fields · synced Jun 8, 2026