Device Dossier
Basic insulin pen, replaceable-cartridge
Device Dossier for Basic insulin pen, replaceable-cartridge (Cartridge-accepting autoinjector, mechanical, Class IIa, sponsor Gedeon Richter). ARTG…
- GMDN category: Cartridge-accepting autoinjector, mechanical
- Sponsor: Gedeon Richter
Intended purpose
A portable, hand-held, mechanical device in the form of a large pen, designed to accept a pharmaceutical-containing cartridge and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and a dial on the device is operated for dosing. The cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.