Syringe, general-purpose

Intended purpose

The Infusion Syringe is a sterile, single-use syringe with a male connector at the distal end (typically a luer-lock/slip type) for the attachment to an intravascular set and needle or catheter. The device is intended to be used by trained healthcare professionals in healthcare facilities on adults for the controlled dilution and continuous infusion of medications indicated for infusion therapy. The device is intended to administer (infuse) the diluted, homogeneous mixture in conjunction with an Infusion Syringe Pump and a specified Therapy Profile. It is indicated for intravenous infusion of medications that may cause allergic or other adverse reactions, requiring continuous delivery at controlled infusion rates (with a maximum allowable infusion rate of at least 20% of the total dose per minute).