INFUTRONIX LLC

Infutronix LLC specializes in electronic infusion pumps, primarily for ambulatory use. Their product line includes non-insulin infusion pumps, patient-controlled analgesia infusion pumps, and single-use electric infusion pump administration sets. These devices are designed for precise medication delivery in both clinical and homecare environments, ensuring controlled and accurate administration of fluids or drugs.

Infutronix LLC is based in the United States. As a manufacturer of medical devices, the company operates under U.S. regulatory requirements, which govern the design, production, and distribution of its infusion pumps and related products to ensure safety and performance.

Yes, Infutronix LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized identifier, ensuring transparency and traceability in the healthcare supply chain. The UDI system is particularly important for Class II devices, which require compliance with specific regulatory controls.

Infutronix LLC’s devices are classified as FDA Class II medical devices. This classification indicates that while they pose moderate risk, they require special controls beyond general controls to ensure their safety and effectiveness. Class II devices undergo additional scrutiny, including performance standards and post-market surveillance, to mitigate potential risks associated with their use.