Identity
- Trade Name
- ONE-CARE Luer-Lock Syringes FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications. FDA UDI
- Model / Reference
- ONE-CARE Luer-Lock Syringes 10ml FDA UDI
- Description
- The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications. FDA UDI
Identifiers
- Catalog Number
- 2006 FDA UDI
- Primary DI / UDI-DI
- 00810008216613 FDA UDI
- FDA Product Code
- FMF FDA UDIFMI FDA UDI
- GMDN Term
- Medication transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 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
- Total Volume — 10 Milliliter FDA UDI
Category: Medication transfer set
ONE-CARE Luer-Lock Syringes by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 9711a2c7-48cf-4c63-8009-b88bd3a2fa9b 37 fields · synced Jun 8, 2026