Identity
- Trade Name
- STAT Medical Devices FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- The Disposable Safety Lancet is intended for capillary blood sampling. FDA UDI
- Model / Reference
- Qwik-Lance Safety Lancet FDA UDI
- Description
- The Disposable Safety Lancet is intended for capillary blood sampling. FDA UDI
Identifiers
- Catalog Number
- RQL-100 FDA UDI
- Primary DI / UDI-DI
- 00709334883883 FDA UDI
- 510(k) Number
- K222408 FDA UDI
- FDA Product Code
- FMK FDA UDI
- GMDN Term
- Manual blood lancing device, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual blood lancing device, single-use
STAT Medical Devices by Stat Medical Devices — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, single-use.
- neoheel — Sterilance Medical (Suzhou) Inc. · Class II
- Unistik 3 — OWEN MUMFORD LIMITED · Class II
- SurgiLance Lite Safety Lancet — MEDIPURPOSE PTE. LTD. · Class II
- AboutTime MPD 21Gx 1.8mm Safety Lancet — Medical Plastic Devices M.P.D. Inc · Class II
- EasyLife Pressure Activated Safety lancet 28G — CARE LIVING DIAGNOSTICS INC · Class II
- ONE-CARE OPTI Safety Lancets — MediVena, LLC · Class II
- GLUCO-CARE Safety Lancets 30G x 1.8 mm — MediVena, LLC · Class II
- STERiLANCE Press2 Disposable Safety Lancet — Sterilance Medical (Suzhou) Inc. · Class II
Cleared under the same submission
K222408 also covers:
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PLUS Safety Lancets — MediVena, LLC
- ONE-CARE PRO Safety Lancets — MediVena, LLC
- ONE-CARE PRO Safety Lancets — MediVena, LLC
- ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm — MediVena, LLC
- ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 2.4mm — MediVena, LLC
- ONE-CARE PRO Safety Lancets, Button-Activated, 25G x 1.6mm — MediVena, LLC
- STAT Medical Devices — Stat Medical Devices
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
- Stat Medical Devices
Sources (1)
- FDA UDI 18b08ebb-e246-4b8e-97cd-a4253a3cb55e 35 fields · synced Jun 7, 2026