Profile: Fresenius Medical Care North America is a provider of products and services for individuals undergoing dialysis. We define the highest standards for the treatment of patients with chronic kidney failure. We offer a complete line of dialysis services and products. Our products include cardioprotective hemodialysis, tubing systems, fistula needles, disinfectants, information technology and dialysis related equipment.
The company has revenues of > USD 1 Billion, has ~37230 employees. NYSE:FMS (SEC Filings)
FDA Registration Number: 2937457
38 Products/Services (Click for related suppliers)
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| • Adult-Pediatric Volumetric Infusion Pumps |
| • Anesthesia Infusion Pump Tubing |
| • Anesthetic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. |
| • 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. |
| • 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. |
| • Blood Temperature Monitoring Devices |
| • Blood Volume Monitoring Devices |
| • Dialysis Fluid Filters |
| • Dialysis Temperature Monitor (FDA Code: FLA / 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. |
| • Dialyzer (FDA Code: JQQ / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use. |
| • Dialyzer Reprocessing System (FDA Code: LIF / 876.5820) |
| • Disposable Kidney Perfusion Kit (FDA Code: KDL / 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. |
| • Dual-Channel Volumetric Infusion Pump |
| • Fistula Needle (FDA Code: FIE / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices. |
| • Hemodiafiltration Systems |
| • Hemodialysis Blood Circuit Accessories (FDA Code: KOC / 876.5820) |
| • Hemodialysis Tubing Kit |
| • Hemodialysis Unit Blood Pump |
| • Hemodialysis Units |
| • 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) |
| • Infusion Pump Analysis System |
| • Infusion Pump Repair |
| • Infusion Pump Service Parts |
| • Infusion Pump Stands |
| • Infusion Pump Tester |
| • Infusion Pumps, Ambulatory Pumps |
| • 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. |
| • Patient Monitor Computer |
| • PCA Pumps, Infusion Pump |
| • Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) |
| • Product Development, Infusion Pumps |
| • Sealed Dialysate Delivery System (FDA Code: FII / 876.5860) |
| • Single Pass Dialysate Delivery System (FDA Code: FIL / 876.5820) |
| • Single Patient Dialysate Delivery System (FDA Code: FKP / 876.5820) |
| • Syringe Infusion Pump |
| • Used Infusion Pumps |
| • Volumetric Infusion Pumps |