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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• Adult-Pediatric Volumetric Infusion Pumps |
• Ambulatory 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. |
• Automated Hemoglobin System (FDA Code: GKR / 864.5620) An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood. |
• 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. |
• AV Shunt Accessories (FDA Code: KNZ / 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. |
• Batteries & Battery Assemblies for Infusion Pumps |
• Blood Oxyhemoglobin Concentration Analyzer |
• Blood Transfusion Sets (FDA Code: BRZ / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. |
• Constant-flow Infusion Pump |
• Diagnostic Automated Blood Cell Separator (FDA Code: GKT / 864.9245) |
• Dialysate Level Detector (FDA Code: FJB / 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. |
• Dialysate Tubing Connector (FDA Code: FKY / 876.5820) |
• Dialysis Catheters |
• Dialysis Solution |
• Dialysis Solution With Dextrose |
• Dialysis System |
• 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. |
• Disposable Peritoneal Dialysis Administration Kit (FDA Code: KDJ / 876.5630) |
• Dual-Channel Volumetric Infusion Pump |
• Femoral Catheter (FDA Code: LFK / 876.5540) |
• Hemodialysis Units |
• Hemofiltration Unit |
• Hemoperfusion System |
• Implanted Programmable Infusion Pump (FDA Code: LKK) |
• Infusion Controller |
• Infusion Pump Analysis System |
• Infusion Pump Repair |
• Infusion Pump Service Parts |
• Infusion Pump Stands |
• Infusion Pump Tester |
• Infusion Pumps, Ambulatory Pumps |
• Intravenous Catheters |
• IV Medication Delivery Systems, volumetric infusion pumps |
• IV Stand Accessories, Multi-Infusion Pump |
• Liquid Disinfector |
• Lumbar Puncture Kit |
• 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. |
• MRI Infusion Pump Systems, Infusion System Accessories |
• Neonatal - Paediatric Intravenous Catheter |
• Parenteral Nutrition Solution |
• PCA Pumps, Infusion Pump |
• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) |
• Peritoneal Dialysis Catheters |
• Peritoneal Dialysis Tubing Kit |
• Peritoneal Dialysis Units |
• Product Development, Hand-held Infusion Pump Controller |
• Product Development, Infusion Pumps |
• Semi-Automatic Peritoneal Dialysate Delivery System (FDA Code: KPF / 876.5630) |