Profile: Rochester Medical Corporation develops and distributes urological & urinary continence care products for urinary dysfunction management & urine drainage management. Our advanced product line includes male external catheters, intermittent urethral catheters, Foley catheters, anti-infection Foleys, and urethral inserts. We also provide latex-free catheter accessories and procedural trays. Our Release-nf® catheter is a technologically advanced anti-bacterial Foley catheter that provides a site-specific, controlled release of the antibacterial agent nitrofurazone. The unique characteristic of the outer surface of the antibacterial personal catheter® renders localized antibacterial activity by delivering nitrofurazone directly to the urethra, when and where protection is needed. Our line of all-silicone Foley catheters is designed to enhance comfort and eliminate risks that may be associated with exposure to latex-containing devices. As an inert, toxin-free material, our silicone is ideal for creating safe, dependable Foley catheters with drainage lumens approximately 30% larger than latex catheters.

The company was founded in 1988, has revenues of USD 25-50 Million and is ISO9001:1994, EN4600:1996, ISO13485:2003 certified.

FDA Registration Number: 2130787

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• Urinary Leg Bags & Accessories

• Urine Collection Leg Bags (FDA Code: FAQ / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urine Collector and Accessories (FDA Code: KNX / 876.5250)

• Urine Leg Bags (FDA Code: FAQ / 876.5250)

• Urological Catheter and Accessories (FDA Code: MJC / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Urological Catheters (FDA Code: KOD / 876.5130)

• Urological Male External Catheters

• Urosheath Type Incontinence Appliance (FDA Code: EXJ / 876.5250)

• Whistle Tip Urethral Catheter