Identity
- Trade Name
- STAT Medical Devices FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. FDA UDI
- Model / Reference
- Comfort Thins Twist-Off Lancet FDA UDI
- Description
- The sterile, single-use lancets is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. FDA UDI
Identifiers
- Catalog Number
- BTM-100 FDA UDI
- Primary DI / UDI-DI
- 00709334581215 FDA UDI
- 510(k) Number
- K222034 FDA UDI
- FDA Product Code
- QRL FDA UDIQRK 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
Yes
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
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Also classified as Manual blood lancing device, single-use.
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- AboutTime MPD 21Gx 1.8mm Safety Lancet — Medical Plastic Devices M.P.D. Inc · Class II
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- 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
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
- Vive Precision — VIVE HEALTH LLC
- RightLance — Visgeneer, Inc.
- 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 |
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Manufacturer
- Manufacturer
- Stat Medical Devices
Sources (1)
- FDA UDI ccccf311-cee6-4fd8-8c09-529da04dfde9 35 fields · synced May 30, 2026