Device Dossier

Infusion kit, intraosseous

Device Dossier for Infusion kit, intraosseous (Infusion kit, intraosseous, Class IIb, sponsor Medical Specialties). ARTG record, intended purpose, GMDN…

Intended purpose

Intraosseous infusion needles are sterile, single-use devices used primarily during paediatric emergencies (children under 24 months of age) as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids. The device is not recommended to be used for longer than a 24-hour period. The device (Intraosseous Infusion Needle) is a needle/handle assembly. The device is manually powered, the Dieckmann design has a positioning mark 1 cm proximal to the needle tip and is available with a trocar tip.

TGA Public Summary