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Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.

The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract. The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The Subject Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO). The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included.

Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract. The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen is a standard non-interconnectable connector.