Identity
- Trade Name
- ONE-CARE Safety Lancets FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure. FDA UDI
- Model / Reference
- 1104 ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, Lime, 100/bx, 20bx/cs FDA UDI
- Description
- ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure. FDA UDI
Identifiers
- Catalog Number
- 1104 FDA UDI
- Primary DI / UDI-DI
- 00810008210123 FDA UDI
- 510(k) Number
- K222376 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDILength — 1.8 Millimeter FDA UDI
Category: Manual blood lancing device, single-use
ONE-CARE Safety Lancets by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222376 also covers:
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- microdot® Pro Gloves — Cambridge Sensors USA, LLC.
- VacSure EZ Care Pressure Activate Safety Lancet — LABOTEK GROUP CORP
- VacSure EZ Care Pressure Activate Safety Lancet — LABOTEK GROUP CORP
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
- MediVena, LLC
Sources (1)
- FDA UDI 38f9d54c-d865-4073-9411-2b5b6712ffc3 38 fields · synced May 30, 2026