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Sign in to claim this brandMediVena, LLC
US
Last updated May 24, 2026
What MediVena, LLC makes
MediVena, LLC manufactures single-use and safety-engineered injection devices for diabetes management and blood sampling, including autoinjector needles, manual blood lancing devices, insulin syringes (both basic and safety variants), and metered-delivery hypodermic syringes. Their portfolio also covers home-use glucose monitoring systems, medication transfer sets, and blood collection tube holders with integrated needles. The company produces both standard and specialized pen needles for insulin delivery, as well as lancets designed for blood glucose testing.
The company’s devices are classified under FDA’s Class I and Class II categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. MediVena, LLC operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MediVena, LLC manufacture?
MediVena, LLC specializes in single-use and safety-engineered injection devices primarily for diabetes management and blood sampling. Their product range includes autoinjector needles, manual blood lancing devices (like lancets), insulin syringes (both basic and safety variants), metered-delivery hypodermic syringes, and glucose monitoring systems designed for home use. They also produce accessories such as medication transfer sets and blood collection tube holders with integrated needles. Many of their devices are designed to reduce user risk, such as safety lancets and pen needles.
Where is MediVena, LLC based, and does that affect the regulatory requirements for their devices?
MediVena, LLC is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including classification under FDA’s Class I or Class II categories. The U.S. jurisdiction also means their products are subject to mandatory listing in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency.
Which regulatory registries or databases list MediVena, LLC’s devices?
MediVena, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for medical devices in the U.S. and serves as an official record of authorized products, including their identification details like model names, manufacturers, and regulatory classifications. Listing in the UDI database ensures transparency and compliance with FDA requirements.
How are MediVena, LLC’s devices classified under FDA regulations?
MediVena, LLC’s devices fall under two primary FDA classifications: Class I and Class II. Class I devices generally pose minimal risk and often require general controls for regulation, while Class II devices involve moderate risk and may require additional performance standards or special controls. The classification depends on factors like the device’s intended use, potential risks, and design complexity—such as whether a product is a basic insulin syringe (Class I) or a safety-engineered pen needle (Class II).
What distinguishes MediVena, LLC’s safety-engineered devices from their standard products?
MediVena, LLC’s safety-engineered devices incorporate design features to reduce the risk of needle-stick injuries or accidental use. For example, their safety lancets and pen needles are engineered to retract, cover, or otherwise protect the needle after use, unlike standard devices that may leave exposed needles. This distinction aligns with Class II classification requirements, where additional controls ensure safer handling without compromising usability for conditions like diabetes management.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medivena.com
- —
- —
- [email protected]
- Phone
- 4045142586
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080740980
Catalogue (110)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gluco-Care | HS100 | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3040-GLUCO-CARE Pen Needles 30G x 8mm, Magenta, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3039-GLUCO-CARE Pen Needles 31G x 8mm, Orange, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Safety Lancets | 1102 ONE-CARE Safety Lancets 28G x 1.8mm, MiniFlow, Purple, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| One-Care | ONE-CARE® OPTI Safety Pen Needles | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Pen Needles | 3104-ONE-CARE PLUS Safety Pen Needles 30G x 8mm, | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3042-GLUCO-CARE Pen Needles 29G x 12.7mm, Red, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, | 3102-ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, | FDA UDI | Class II | Active |
| GLUCO-CARE PLUS Pen Needles | 3025 GLUCO-CARE PLUS Pen Needles, 33G x 4mm | FDA UDI | Class II | Active |
| ONE-CARE Alcohol Prep Pads | ONE-CARE Alcohol Prep Pads, 70%, M, Box of 200 | FDA UDI | Class I | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2"(12.7mm), U-100, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE OPTI Insulin Safety Syringes | ONE-CARE OPTI Insulin Safety Syringes, 1mL, 29Gx 0.5 | FDA UDI | Class II | Active |
| ONE-CARE Safety Blood Collection Needles | 5021-H ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' with Holders | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5062-H ONE-CARE PRESS & LOCK SBCWS 21G x 0.75’’, Pre-Attached Holder, 12'' Tube | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3038-GLUCO-CARE Pen Needles, 31G x 6mm, Blue, 100bx, 50bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles 33G x 4mm | 3031 GLUCO-CARE Pen Needles 33G x 4mm | FDA UDI | Class II | Active |
| GLUCO-CARE Safety Lancets 30G x 1.8 mm | GLUCO-CARE Safety Lancets 30G x 1.8 mm | FDA UDI | Class II | Active |
| One-Care | AC500 | FDA UDI | Class II | Active |
| One-Care | AC500 PRO | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3036-GLUCO-CARE Pen Needles 31G x 4mm, Sky Blue, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 0.3ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10,100/bx | FDA UDI | Class II | Active |
| ONE-CARE Luer-Lock Syringes | ONE-CARE Luer-Lock Syringes 60ml | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5062 ONE-CARE PRESS & LOCK SBCWS 21G x 0.75’’, Luer Adapter, 12'' Tube | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3035-GLUCO-CARE Pen Needles 32G x 8mm, Grey, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Pen Needles | 3013-ONE-CARE Pen Needles 32G x 5mm, Brown, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm | ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Pen Needles 30G x 5mm, | 3103-ONE-CARE PLUS Safety Pen Needles 30G x 5mm, | FDA UDI | Class II | Active |
| ONE-CARE Safety Lancets | 1101 ONE-CARE Safety Lancets 30G x 1.5mm, MicroFlow, Pink, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles, 32G x 4mm | 3032 GLUCO-CARE Pen Needles, 32G x 4mm | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 0.5ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3041-GLUCO-CARE Pen Needles 29G x 10mm, Green, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 1ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10, 100/bx, | FDA UDI | Class II | Active |
| ONE-CARE Non-Contact Infrared Thermometer | 4021 ONE-CARE Non-Contact Infrared Thermometer HTD8818A | FDA UDI | Class II | Active |
| ONE-CARE Pen Needles, | 3018-ONE-CARE Pen Needles, 31G x 6mm, Blue, 100ct, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Luer-Lock Syringes | ONE-CARE Luer-Lock Syringes 1ml | FDA UDI | Class II | Active |
| ONE-CARE Safety Lancets | 1103 ONE-CARE Safety Lancets 26G x 1.8mm, LowFlow, Blue, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Safety Lancets, Contact-Activated, 21Gx 1.8mm | GLUCO-CARE Safety Lancets, Contact-Activated, 21Gx 1.8mm | FDA UDI | Class II | Active |
| ONE-CARE Insulin Safety Syringes | ONE-CARE Insulin Safety Syringe, 0.5mL, 29G x 0.5 inch | FDA UDI | Class II | Active |
| GLUCO-CARE Safety Lancets, Contact-Activated, 26Gx 1.8mm | GLUCO-CARE Safety Lancets, Contact-Activated, 26Gx 1.8mm | FDA UDI | Class II | Active |
| ONE-CARE Safety Blood Collection Needles | 5020-H ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders | FDA UDI | Class II | Active |
| One-Care | AC500 | FDA UDI | Class II | Active |
| ONE-CARE Non-Contact Infrared Thermometer | 4020 ONE-CARE Non-Contact Infrared Thermometer HTD8813C | FDA UDI | Class II | Active |
| ONE-CARE Luer-Lock Syringes | ONE-CARE Luer-Lock Syringes 5ml | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3035-GLUCO-CARE Pen Needles 32G x 8mm, Grey, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE OPTI Insulin Safety Syringes | ONE-CARE OPTI Insulin Safety Syringes 0.3ml 29G x 1/2'' | FDA UDI | Class II | Active |
| ONE-CARE PRO Safety Lancets, Button-Activated, 25G x 1.6mm | ONE-CARE PRO Safety Lancets, Button-Activated, 25G x 1.6mm | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Lancets | 1006 ONE-CARE PLUS Safety Lancets 21G / 2.8mm, MaxFlow, Orange, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE OPTI Safety Lancets | ONE-CARE OPTI Safety Lancets Top Button Activated, 21G x 2.8mm, 200bx, 18bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3039-GLUCO-CARE Pen Needles 31G x 8mm, Orange, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5060 ONE-CARE PRESS & LOCK SBCWS 25G x 0.75’’, Luer Adapter, 12'' Tube | FDA UDI | Class II | Active |
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