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The Colorado Catheter iCath™ and SterileSure™ are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

The iCath" and SterileSure™ are intended to be disposable medical devices that offer a pre-lubricated self catheterization alternative that does not require the application of lubricant prior to use to facilitate the insertion of a urinary catheter. Although nearly identical, the iCath™ is designed and intended for outpatient use, and the SterileSure™ is designed and intended for inpatient use administered to a patient under the care of medical personnel. The iCath" and SterileSure™ are intended to be used to drain urine from the bladder. The devices are provided sterile and for single-use only. Both consist of a catheter assembled within a thin, flexible sheath to minimize patient contact and reduce contamination. The sheath is connected to an introducer tip that is inserted into the urethra to facilitate advancement of the catheter into the urethra. The introducer tip of the iCath™ contains a lubricant reservoir feature in which the catheter is lubricated prior to insertion with a watcr-soluble hydrophilic water-based lubricant. The SterileSure™ is prelubricated with the water-soluble hydrophilic waterbased lubricant. The devices are packaged singly with a urine drainage bag, or in a kit with accessories including benzalkonium chloride swabsticks or provodine iodine swabsticks, gauze pad, and urine collection container or urine drainage bag, and non-latex, powder-free gloves