Identity
- Trade Name
- RightLance FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- reusable lancing device that is to be cleaned and disinfected between each use, to be used with the sterile single-use lancets FDA UDI
- Model / Reference
- RC-AD-VIU FDA UDI
- Description
- reusable lancing device that is to be cleaned and disinfected between each use, to be used with the sterile single-use lancets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04712558762694 FDA UDI
- 510(k) Number
- K222034 FDA UDI
- FDA Product Code
- QRL FDA UDI
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 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
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual blood lancing device, reusable
RightLance by Visgeneer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual blood lancing device, reusable.
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- 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
K222034 also covers:
- EasyTouch — MHC Medical Products
- Members Mark — MHC Medical Products
- Members Mark — MHC Medical Products
- Members Mark — MHC Medical Products
- STAT Medical Devices — Stat Medical Devices
- STAT Medical Devices — Stat Medical Devices
- Vive Precision — VIVE HEALTH LLC
- Visgeneer — Visgeneer, Inc.
- Members Mark — Walmart Stores
- Members Mark — Walmart Stores
- Members Mark — Walmart Stores
- CareSoft — i-SENS, Inc.
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
- Visgeneer, Inc.
Sources (1)
- FDA UDI b541fa94-a4d4-475a-b2e3-4c2cf044cbf2 34 fields · synced May 30, 2026