Fresenius Medical Care AG & Co. KGaA

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Contact: Marcus Spohn
E-Mail:
Address: Else-Kröner-Straße 1, Bad Homburg 61352, Germany
Phone: +49-(6172)-6090 | Fax: +49-(6172)-6092301 | Map/Directions >>

Profile: Fresenius Medical Care AG & Co. KGaA specializes in providing products and services for individuals undergoing dialysis because of chronic kidney failure. We provide a complete line of dialysis services and products. We provide a range of drugs for treating patients with chronic and acute renal failure. The initial portfolio of dialysis-related drugs comprises phosphate binders, potassium binders, and a novel drug for anemia management. The multifiltrate is optimally designed to carry out highly efficient therapies in the nephrological and intensive care environment. It features an ergonomically, intuitive operating concept, which incorporates a wide range of additional renal replacement therapies. The hemofilter Ultraflux is specifically developed for continuous renal replacement treatment (CRRT). The Ultraflux filters contain a fresenius polysulfone membrane specially developed for continuous renal replacement therapy. With this membrane, substances with a molecular weight of up to approximately 30,000 Dalton can be eliminated, but plasma proteins like albumin, bigger molecules and cellular blood constituents are retained. The filtration characteristics of this membrane come close to the natural human kidney's glomeruli. Due to their high mechanical stability and excellent filter lifetimes, the Ultraflux filters AV 400S, AV600S and AV 1000S are tailor-made for use in all continuous renal replacement treatments.

FDA Registration Number: 9611823
US Agent: Denise Oppermann / Senior Director Of Regulatory Affairs, Devices
Phone: +1-(781)-699-4479 Fax: +1-(781)-699-9635 E-Mail:

5 Products/Services (Click for related suppliers)

• Autotransfusion Apparatus (FDA Code: CAC / 868.5830)

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 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.

• High Permeability with/without Sealed Dialysate System (FDA Code: KDI / 876.5860)

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

• Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 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.

• Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890)

A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.