Identity
- Trade Name
- ONE-CARE PLUS Safety Lancets FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- Contact-activated ONE-CARE PLUS Safety Lancets 25G x 1.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience. FDA UDI
- Model / Reference
- 1003 ONE-CARE PLUS Safety Lancets 25G x 1.8mm, LowFlow, Sky Blue, 100/bx, 20bx/c FDA UDI
- Description
- Contact-activated ONE-CARE PLUS Safety Lancets 25G x 1.8 mm are designed with an ergonomic body for a comfortable grip, ensuring ease of use during procedures. The reliable safety activation mechanism guarantees consistent performance, while the wide cap allows for easy twist-off, facilitating straightforward preparation for use. This innovative design provides an optimal combination of safety, comfort, and convenience. FDA UDI
Identifiers
- Catalog Number
- 1003 FDA UDI
- Primary DI / UDI-DI
- 00810008210192 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDILength — 1.8 Millimeter FDA UDI
Category: Manual blood lancing device, single-use
ONE-CARE PLUS Safety Lancets by MediVena, LLC — 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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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 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
- 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
- MediVena, LLC
Sources (1)
- FDA UDI 1a868de7-ff4a-42f1-aeaa-4ff82ffdf5d7 38 fields · synced May 30, 2026