Device Dossier
Cover, stoma protection
Device Dossier for Cover, stoma protection (Cover, stoma protection, Class IIa, sponsor New Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Cover, stoma protection
Intended purpose
The Aquaflush ACE Stoma Stopper is used by patients with a stoma to allow the stoma to remain patent in between catheterisations. The Aquaflush ACE Stoma Stopper is made from a medical grade silicone licensed for 30 days intermittent use in a single patient only. The Aquaflush ACE Stoma Stopper is licensed to be cut to length to suit an individual patient's stoma from between 10-100 mm and has graduations to facilitate this. The Aquaflush ACE Stoma Stopper should not be used in patients that are allergic to medical grade silicone and should be replaced after 30 days use.