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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 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ONE-CARE OPTI Safety Lancets | ONE-CARE OPTI Safety Lancets Top Button Activated, 23G x 1.8mm, 200bx, 18bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Safety Lancets | 1107 ONE-CARE Safety Lancets 18G x 1.8mm, MaxFlow, Orange, 100/bx, 20bx/cs | 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 |
| ONE-CARE PLUS Safety Lancets | 1005 ONE-CARE PLUS Safety Lancets 21G x 2.4mm, ExtraFlow, Green, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Safety Blood Collection Needles | 5022-H ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' with Holders | FDA UDI | Class II | Active |
| Gluco-Care | HS100 | FDA UDI | Class II | Active |
| ONE-CARE Pen Needles | 3014-ONE-CARE Pen Needles 32G x 6mm, Yellow, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| Gluco-Care | HS100 | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 1 ml 31G x 1/4" (6mm), 10/bg x 10, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Safety Pen Needles 30G x 5mm, Pink, | 3101-ONE-CARE Safety Pen Needles 30G x 5mm, Pink, | FDA UDI | Class II | Active |
| GLUCO-CARE PLUS Pen Needles | 3028-GLUCO-CARE PLUS Pen Needles, 31G x 8mm, Orange, 100ct, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Lancets | 1001 ONE-CARE PLUS Safety Lancets 30G x 1.5mm, MicroFlow, Purple, 100/bx, 20bx/c | FDA UDI | Class II | Active |
| GLUCO-CARE PLUS Pen Needles | 3024 GLUCO-CARE PLUS Pen Needles, 32G x 6mm | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/bx, | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2"(12.7mm), U-100, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3040-GLUCO-CARE Pen Needles 30G x 8mm, Magenta, 100/bx, 50bx/ | FDA UDI | Class II | Active |
| One-Care | AC500 | FDA UDI | Class I | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b | FDA UDI | Class II | Active |
| ONE-CARE Safety Blood Collection Needles | 5022 ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' without Holders | FDA UDI | Class II | Active |
| ONE-CARE Pen Needles | 3012-ONE-CARE Pen Needles, 32G x 4mm, Green, 100ct, 50bx/cs | FDA UDI | Class II | Active |
| ONE-CARE TB Safety Syringes | ONE-CARE TB Safety Syringes, 1mL, 28G x 0.5’’ | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5060-H ONE-CARE PRESS & LOCK SBCWS 25G x 0.75’’, Pre-Attached Holder, 12'' Tube | FDA UDI | Class II | Active |
| One-Care | AC500 PRO | FDA UDI | Class II | Active |
| ONE-CARE OPTI Safety Lancets | ONE-CARE OPTI Safety Lancets Top Button Activated, 21G x 1.8mm, 200bx, 18bx/cs | FDA UDI | Class II | Active |
| ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm) | ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5'’ (12.7mm) | FDA UDI | Class II | Active |
| ONE-CARE TB Safety Syringes | ONE-CARE TB Safety Syringes, 1mL, 27G x 0.5'' | 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 |
| ONE-CARE Pen Needles | 3019-ONE-CARE Pen Needles 31G x 8mm, Orange, 100/bx, 50bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE PLUS Pen Needles | 3022 GLUCO-CARE PLUS Pen Needles, 32G x 4mm | FDA UDI | Class II | Active |
| ONE-CARE PRO Safety Lancets | ONE-CARE PRO Safety Lancets, Button-Activated, 30G x 1.2mm | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Lancets | 1003 ONE-CARE PLUS Safety Lancets 25G x 1.8mm, LowFlow, Sky Blue, 100/bx, 20bx/c | 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 Luer-Lock Syringes | ONE-CARE Luer-Lock Syringes 3ml | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles | 3037-GLUCO-CARE Pen Needles, 31G x 5mm, Purple, 100bx, 50bx/cs | 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 |
| ONE-CARE OPTI Safety Lancets | 1032 ONE-CARE OPTI Safety Lancets Top Button Activated, 28G x 1.6mm, 200bx, 18bx | FDA UDI | Class II | Active |
| One-Care | ONE-CARE OPTI Safety Pen Needles 30G x 8mm | FDA UDI | Class II | Active |
| GLUCO-CARE PLUS Pen Needles | 3023 GLUCO-CARE PLUS Pen Needles, 32G x 5mm | FDA UDI | Class II | Active |
| ONE-CARE Safety Blood Collection Needles | 5021 ONE-CARE Safety Blood Collection Needles 21G x 1 1/4'' without Holders | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5061 ONE-CARE PRESS & LOCK SBCWS 23G x 0.75’’, Luer Adapter, 12'' Tube | FDA UDI | Class II | Active |
| ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets | 5061-H ONE-CARE PRESS & LOCK SBCWS 23G x 0.75’’, Pre-Attached Holder, 12'' Tube | FDA UDI | Class II | Active |
| ONE-CARE Insulin Safety Syringes | ONE-CARE Insulin Safety Syringes, 1mL, 29G x 0.5 inch | FDA UDI | Class II | Active |
| GLUCO-CARE Insulin Syringes | GLUCO-CARE Insulin Syringes 0.5ml 31G x 1/4" (6mm), 10/bg x 10,100/bx, 20bx/cs | FDA UDI | Class II | Active |
| One-Care | ONE-CARE DUO Safety Pen Needles | FDA UDI | Class II | Active |
| ONE-CARE TB Safety Syringes | ONE-CARE TB Safety Syringes, 1mL, 25G x 5/8’’ | FDA UDI | Class II | Active |
| ONE-CARE Safety Lancets | 1104 ONE-CARE Safety Lancets 23G x 1.8mm, NormalFlow, Lime, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE PLUS Safety Lancets | 1004 ONE-CARE PLUS Safety Lancets 21G x 1.8mm, NormalFlow, Blue, 100/bx, 20bx/cs | FDA UDI | Class II | Active |
| ONE-CARE Luer-Lock Syringes | ONE-CARE Luer-Lock Syringes 10ml | FDA UDI | Class II | Active |
| ONE-CARE OPTI Safety Lancets | ONE-CARE OPTI Safety Lancets Top Button Activated, 21G x 2.4mm, 200bx, 18bx/cs | FDA UDI | Class II | Active |
| GLUCO-CARE Pen Needles, | 3037-GLUCO-CARE Pen Needles, 31G x 5mm, Purple, 100bx, 50bx/cs | FDA UDI | Class II | Active |
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