Profile: PIE Medical International, Inc. specializes in providing bowel prosthetic device. Our bowel prosthetic system introduces timed pulsed, body temperature tap water under low pressure (2.5 PSI) into the colon, thereby irrigating the stool completely to the cecum, breaking up solid feces for natural gravity evacuation.
FDA Registration Number: 1061032
3 Products/Services (Click for related suppliers)
|
| • Bowel Management Kits |
| • Bowel Management Tube Accessories |
| • Colonic Irrigation System (FDA Code: KPL / 876.5220) A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (876.5210). |