Device Dossier
Allurion Filler Kit - Balloon, gastric, appetite-suppressing
Device Dossier for Allurion Filler Kit - Balloon, gastric, appetite-suppressing (Balloon, gastric, appetite-suppressing, Class IIb, sponsor Emergo). ARTG…
- GMDN category: Balloon, gastric, appetite-suppressing
Intended purpose
This device is a component of a Gastric Balloon System. This filler kit aids in the filling of the device, and is provided with: a filler bag containing filling fluid; an extension hose with a flow indicator, a spike to pierce the filler bag septum port and a blue stopcock to connect to the delivery catheter; and a syringe that, if needed, can be connected to the delivery catheter and used to evacuate or fill the balloon.