MediVena, LLC

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.

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.

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.

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).

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.