Device Dossier
Electronic insulin pen
Device Dossier for Electronic insulin pen (Empty self-injector, electronic, Class IIa, sponsor Pfizer). ARTG record, intended purpose, GMDN category —…
- GMDN category: Empty self-injector, electronic
- Sponsor: Pfizer
Intended purpose
This device is an electrical, auto-injector that is used with a dedicated Dose Dispenser Cartridge (DDC) under a home healthcare environment. The injector is for the self-injection of a subcutaneous dose of Tumor-Necrosis Factor inhibitors in the DDC. Patients are separately prescribed the DDC by healthcare professionals.