Identity
- Trade Name
- OneTouch Ultramini FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Device Name
- OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip FDA UDI
- Model / Reference
- 021-422 FDA UDI
- Description
- OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip FDA UDI
Identifiers
- Catalog Number
- 021-422 FDA UDI
- Primary DI / UDI-DI
- 00353885001311 FDA UDI
- 510(k) Number
- K061118 FDA UDI
- FDA Product Code
- NBW 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
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 IVD, kit, electrometryBlood lancing device tipManual blood lancing device, reusableGlucose analyser IVD, home-use
OneTouch Ultramini by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose analyser IVD, home-use.
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Cleared under the same submission
K061118 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 2405e733-3e9d-4d49-9b72-ee5d99dc213c 38 fields · synced May 31, 2026