Profile: Waters Medical Systems®, LLC manufactures medical devices for kidney transplant perfusion and heart oxygen saturation measurement. Our product brands include RM3 and OXICOM. Our RM3 is a pulsatile renal preservation system that accurately controls pressure, flow, and temperature while a hypothermic perfusate solution is continuously pumped through the organ to improve the success rate of a kidney transplant. The unique RM3 monitor provides legible, real-time data on the condition of the stored kidneys and delivers all the information to an RS232 port. The monitor displays pulse pump rate, perfusate temperature, systolic, mean & diastolic pressure, real time flow, and renal resistance. Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation.
The company was founded in 1960, has revenues of USD 25-50 Million, has ~170 employees and is ISO 9002, CE certified.
FDA Registration Number: 2123774
5 Products/Services (Click for related suppliers)
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• Kidney Perfusion System (FDA Code: KDN / 876.5880) An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set. |
• Organ Preservation System |
• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. |
• Renal Preservation Systems |
• Whole Blood Oximeter (FDA Code: GLY / 864.7500) A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems. |