Profile: Medionics International Inc. specializes in the design and manufacture of peritoneal dialysis equipment and disposables including catheters. We produce custom disposable medical devices with capabilities ranging from RF and ultrasonic welding, to heat sealing, hot stamping, assembly and packaging. We provide Selectra peritoneal dialysis machine for CAPD, CCPD, NPD, IPD and manual dialysis. It combines the best features of the revolutionary microprocessor technology with our in-depth clinical knowledge of peritoneal dialysis techniques to provide reliable services and the utmost in patient safety.
The company was founded in 1976, has ~40 employees and is ISO-9001, ISO-13485, CE certified.
FDA Registration Number: 9611088
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997 Fax: +1-(512)-327-9998 E-Mail:
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• Automatic Delivery Peritoneal System (FDA Code: FKX / 876.5630) (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system. |
• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 876.5630) |
• Long-Term Indwelling Peritoneal Catheter (FDA Code: FJS / 876.5630) |
• Peritoneal Dialysis Catheters |
• Peritoneal Dialysis Cycler |
• Peritoneal Dialysis Tubing Kit |
• Peritoneal Dialysis Units |