Device typeUrinary incontinence penis sheath/port, single-use: A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
FDA categoryDEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
Device ID00801741071041
Catalog number36302
AvailabilityOver the counter
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information
Circumference29 Millimeter