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Address: 2637 Shadelands Dr., Walnut Creek, California 94598, USA
www.fmc-ag.com |
Phone: +1-(800)-227-2572
FDA Registration: 2937457 Annual Revenues: > USD 1 Billion
Employee Count: ~37230
Products: Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code:
FRN), Adult-Pediatric Volumetric Infusion Pumps, Autotransfusion Apparatus (FDA Code:
CAC), Automatic Delivery Peritoneal System (FDA Code:
FKX), Dialysis Temperature Monitor (FDA Code:
FLA), ...
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 failu
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Address: 3000 Wilson Ave., Leavenworth, Kansas 66048, USA
www.heatron.com |
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Phone: +1-(913)-651-4420
Annual Revenues: USD 25-50 Million
Employee Count: ~300
Quality: ISO 9001 Certified
Products: AC-Powered Heart-Lung Bypass Heat Exchanger, Cardiopulmonary Bypass Heat Exchanger (FDA Code:
DTR), Contract Manufacturing, Electrical Instrument Heater, Engineering/Design Service, Dialysis Temperature Monitor (FDA Code:
FLA), ...
Heatron, Inc. specializes in the range of medical applications that include medical devices and equipment, life sciences, patient care, laboratory equipment & diagnostics. Our cartridge heaters are us
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Address: No. 660, Jalan Idaman 3/4, Taman Desa, Idaman, Kawasan Perindustrian Senai, Johor Senai, MY-01 81400, Malaysia
Products: Dialysis Temperature Monitor (FDA Code:
FLA), ...
Scandinavian Wireless Electronics Sdn. Bhd is a manufacturer of dialysis monitoring alarm systems.
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FDA Code / Regulation: 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.
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.