410 Medical Innovation, LLC

410 Medical Innovation, LLC specializes in blood transfusion and intravenous administration devices. Their primary products include rapid infusion systems, blood infusers, and replacement tubing sets, all designed specifically for medical transfusion procedures. These devices are engineered to facilitate efficient and safe blood or fluid administration in clinical settings.

410 Medical Innovation, LLC is based in the United States. The company’s operations and product development are centered within the country, though specific locations or facilities are not provided in the available data.

The devices produced by 410 Medical Innovation, LLC are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track and identify medical devices that have undergone the necessary regulatory processes, including classification and clearance requirements.

The devices manufactured by 410 Medical Innovation, LLC are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. The specific controls for these devices are outlined in FDA guidance and regulations.