Profile: Sewoon Medical Co., Ltd. is a manufacturer of wound drainage systems, urinary catheters & tubes, tracheal tubes, infusion devices and drainage catheters & tubes. Our silicone foley balloon catheters are available in various colors. This three way balloon retention catheters are used for the continuous bladder irrigation and drainage at the same time. The plastic valve in the catheter allows easy inflation of the balloon and fits all common slip luer syringes. The color coded bands allow easy distinction of sizes. Our sewoon ventricular drainage catheters are manufactured for continuous drainage of Cerebro Spinal Fluid (CSF) to improve neuro-surgical conditions. This complete kit contains external ventricular drainage catheter with radiopaque & tip, stylet & trocar needle, luer lock connector & cap and anchor. Our external ventricular drainage circuit & bag consist of collection bag, circuit tubing set and drip chamber. The inlet end of the tubing set has a luer adapter which accepts the ventricular catheter adapter.
The company is ISO9001, ISO13485 and CE Mark certified.
FDA Registration Number: 3000247987
US Agent: Robert P Eaton / 3t Medical Systems Inc.
Phone: +1-(734)-525-9580 Fax: +1-(734)-525-9582 E-Mail:
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• Balloon Retention Type Catheter (FDA Code: EZL / 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). |
• Breathing Tube Support (FDA Code: JAY / 868.5280) A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s). |
• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. |
• Ostomy Drainage Bag (FDA Code: FON / 876.5900) An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds. |
• Suction Catheter and Tip (FDA Code: JOL / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). |
• Tracheal Tube Stylet (FDA Code: BSR / 868.5790) A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. |
• Urinary Drainage Collection Kit (FDA Code: FCN / 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: |