Profile: Fresenius is a global health care company with products and services for dialysis, hospitals & the medical care of patients at home. We deal with hemodialysis, acute dialysis, peritoneal dialysis, dialysis care, spectra laboratories, liver support therapy and therapeutical apheresis. Someof our automatic peritoneal dialysis systems are sleep-safe, PD-Night, Freedom Cycler, 90/2 and Newton IQ. They have a user-friendly software that makes them simple and safe to use. They are also easy to transport and allow patients to sleep peacefully during treatment. Our sleep.safe complies with the most modern technological standards. It has a hydraulic pump that performs the fluid exchange, which is controlled by several pressure sensors. A microprocessor monitors the treatment steps. The bags are connected automatically and an integrated heater warms the dialysis fluid before it is injected into the patient's abdominal cavity. PD-Night is a special version of sleep.safe designed for the treatment of children.

The company has revenues of USD 1-5 Million, has ~7350 employees and is ISO 9000, CE certified.

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• Single Patient Dialysate Delivery System (FDA Code: FKP / 876.5820) A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Single-Use Peritoneal Dialysis Catheter (FDA Code: FKO / 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.

• Sorbent Hemoperfusion System (FDA Code: FLD / 876.5870) A sorbent hemoperfusion system is a device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (876.5820) and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.

• Syringe Infusion Pump

• Used Infusion Pumps

• Vascular Access Port

• Volumetric Infusion Pumps

• 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.

• Wound Drainage Kit