Identity
- Trade Name
- OneTouch Verio FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Device Name
- OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only. FDA UDI
- Model / Reference
- 022-657 FDA UDI
- Description
- OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only. FDA UDI
Identifiers
- Catalog Number
- 022-657 FDA UDI
- Primary DI / UDI-DI
- 00353885008716 FDA UDI
- 510(k) Number
- K131363 FDA UDI
- FDA Product Code
- NBW FDA UDILFR 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 monitoring system IVD, home-useBlood lancing device tipManual blood lancing device, reusableGlucose analyser IVD, home-use
OneTouch Verio by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose analyser IVD, home-use.
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- CURO A1c — KPI HEALTHCARE, INC. · Class II
Cleared under the same submission
K131363 also covers:
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio — Lifescan Europe
- OneTouch Verio Blood Glucose Monitoring System. — Lifescan Europe
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifescan Europe
Sources (1)
- FDA UDI 43e67605-5523-4b5d-806a-d3eb3eb8b88e 38 fields · synced Jun 8, 2026