Device Dossier

Insulin syringe, fixed-needle

Device Dossier for Insulin syringe, fixed-needle (Insulin syringe, fixed-needle, Class IIa, sponsor Icon Medipharm). ARTG record, intended purpose, GMDN…

Intended purpose

A sterile device consisting of a calibrated barrel (cylinder) with plunger, with a permanently-attached needle (usually capped for user protection), intended to be used to administer an injection of insulin to a patient subcutaneously. It is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally coated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

TGA Public Summary