Device typePenis wearable urinal: An externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
FDA categoryDevice, Paste-On For Incontinence, Non-Sterile
Device ID00653599001677
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information