Identity
- Trade Name
- OneTouch Verio IQ FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing FDA UDI
- Model / Reference
- 022-268 FDA UDI
- Description
- OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing FDA UDI
Identifiers
- Catalog Number
- 022-268 FDA UDI
- Primary DI / UDI-DI
- 00353885007719 FDA UDI
- 510(k) Number
- K110637 FDA UDI
- FDA Product Code
- LFR FDA UDINBW 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
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 Verio IQ by Lifescan Europe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose IVD, control.
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Cleared under the same submission
K110637 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 IQ — Lifescan Europe
- OneTouch Verio IQ — 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 249266ad-1259-4e61-b6cf-1df314be2eee 38 fields · synced Jun 6, 2026