Device Dossier
Catheter, urological, Foley
Device Dossier for Catheter, urological, Foley (Catheter, urological, Foley, Class IIb, sponsor Coloplast). ARTG record, intended purpose, GMDN category…
- GMDN category: Catheter, urological, Foley
Intended purpose
The devices are intended to be used for: - Bladder drainage by urethral catheterization, or by suprapubic catheterization (only for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL). - Bladder instillation of physiological saline solution. - Post-operative bladder irrigation-lavage by urethral catheterization, only for 3-way Folysil® catheters for neobladder.