Non Invasive I.V. Therapy Medical Devices

Blood transfusion sets - are intended for administration of blood or blood components (e.g. packed red blood cells, platelets and fresh frozen plasma) to patients that require replacement of fluid. Blood Syringe Sets -are intended to deliver blood, blood components or solutions from a container into the patient’s vascular system through a vascular access device. Extension Sets -are intended for intermittent or continuous administration of fluids that can be connected with an I.V. Set which is used in combination with infusion pumps using active pumping mechanisms. The devices allow connection to patient access sites insulating the site from mechanical solicitation, connection to other medical devices to extend their basic length, connection to fluid sources, and to add features such as on-off control of flow, multi-directional control of flow, visual check of flow, filtration and introduction of secondary medications trough Luer-lock connectors, needle free injection sites or stopcock. Syringe Sets and Standalone Devices -are intended to deliver fluids from a container into the patient’s vascular system through a vascular access device. In addition, these devices may also be used to extend the length of a primary administration set and/or may add specific in-line features including, but not limited to, filters, valves and clamps. Pump sets -are used for administration of drugs, where dosage precision is critical. Some sets for specialty therapy, e.g. Chemotherapy sets, are used for administration of drugs with increased reactivity. The fluid is channeled from an IV container (e.g. collapsible bag, glass container) through the set to an IV access / port to the patient’s vascular system. The flow rate is determined by the settings on the electromechanical infusion pump and the corresponding precision tubing. Pump sets may be used with a dedicated electromechanical pump (e.g. Colleague Infusion pump) or in the gravity mode. Needleless injection sites -are intended for use with an indwelling intra-vascular catheter for blood sampling and the administration of solutions. This devices have been designed to be connected to other devices without the need of a standard steel needle to help prevent needle stick injuries. The One-Link needle-free connector -is used as in-line injection site that can be connected with standard male Luer connectors to a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential risk for needle-stick injuries during use. One-Link Catheter Extension Sets -are Extension Sets incorporating one or more One-Link needle-free connectors; they are intended for intermittent or continuous administration of fluid and to withdraw fluids. Some One-Link Catheter Extension Sets may be connected to low pressure power injectors generating a pressure up to 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.