Device Dossier

Insulin syringe, fixed-needle

Device Dossier for Insulin syringe, fixed-needle (Insulin syringe, fixed-needle, Class IIa, sponsor H ALJABIRI & P.A BRAITHWAITE-BASIL). ARTG record,…

Intended purpose

A sterile, single-use syringe with a permanently attached needle, designed for the subcutaneous injection of insulin and other medications requiring subcutaneous delivery. The device is intended for use in the management of diabetes mellitus and other medical conditions requiring self-administration or clinician-administered subcutaneous injections in adult and paediatric patients. The device consists of a syringe barrel graduated in insulin units (U-100), a rubber plunger stopper, a plunger rod, and a permanently attached hypodermic needle with a protective needle cap. The barrel is calibrated to allow accurate dose measurement and is manufactured from medical-grade materials compatible with insulin and other subcutaneous medications. The needle is manufactured from medical-grade stainless steel. The device is supplied in sterile packaging and is intended for single use by a single patient only, after which it should be disposed of in accordance with local sharps disposal regulations. The device is not intended for intravenous, intramuscular, or intrathecal administration. The device is not intended for use with infusion pumps or other powered delivery systems. Available in a range of needle gauges and lengths to accommodate varying patient needs and clinical requirements.

TGA Public Summary