Identity
- Trade Name
- ONE-CARE PRO Safety Lancets FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container. FDA UDI
- Model / Reference
- ONE-CARE PRO Safety Lancets, Button-Activated, 30G x 1.2mm FDA UDI
- Description
- MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container. FDA UDI
Identifiers
- Catalog Number
- 1011 FDA UDI
- Primary DI / UDI-DI
- 00810008210642 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 — 30 Gauge FDA UDILength — 1.2 Millimeter FDA UDI
Category: Manual blood lancing device, single-use
ONE-CARE PRO 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
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, 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 1223b51d-2892-4bfb-bab2-f07232d2baa1 38 fields · synced Jun 6, 2026