Device Dossier

General-purpose infusion pump, battery-powered

Device Dossier for General-purpose infusion pump, battery-powered (General-purpose infusion pump, battery-powered, Class IIb, sponsor Becton Dickinson).…

Intended purpose

For infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, intrathecal, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral fluids, biosimilars, chemotherapeutic agents, blood or blood products infusion, and general fluids therapy in hospital and home care environments.

TGA Public Summary