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Address: PO Box 2081, Palm Harbor, Florida 34682-2081, USA
www.apheresis.com |
Send Inquiry |
Phone: +1-(727)-787-5616, 800-749-9284
Year Established: 1990
Annual Revenues: < USD 1 Million
Quality: ISO 9001 Certified
Products: Plasma Separator, Anti-Regurgitation Valve with Blood Tubing Set (FDA Code:
FJK), Dialysate Tube (FDA Code:
FID), Dialysis Blood Filter (FDA Code:
FKJ), Extra-Luminal Blood Pump (FDA Code:
FIR), Hemodialysis Blood Circuit Accessories (FDA Code:
KOC), ...
Apheresis Technologies, Inc. is a distributor of plasma separators. We provide plasma filters. We design, manufacture and distribute ancillary products for use with the Plasmaflo™. These product
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Address: 14605 28th Avenue N., Minneapolis, Minnesota 55447, USA
www.minntech.com |
Send Inquiry |
Phone: +1-(763)-553-3300, 800-328-3345
FDA Registration: 2150060 Year Established: 1974
Annual Revenues: USD 25-50 Million
Employee Count: ~400
Quality: ISO 9001, CE Certified
Products: Air Bubble Detectors (FDA Code:
FJF), Air Bubble Monitor (FDA Code:
FJF), Cardiopulmonary Bypass Accessories (FDA Code:
KRI), Cardiopulmonary Bypass Oxygenator (FDA Code:
DTZ), Central Multiple Patient Dialysate Delivery System (FDA Code:
FKQ), Bicarbonate Hemodialysis Concentrates, ...
Minntech Corporation develops, manufactures and markets medical devices, sterilants, & water purification products. We also develop core technologies in hollow fiber membrane devices, chemical sterila
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Address: Boseind 15, Rm Boxtel B-5281, Netherlands
www.organonteknika.com |
Phone: +31-(411)-654486
Annual Revenues: USD 100-500 Million
Employee Count: ~2250
Quality: ISO 9001, CE Certified
Products: Coagulation Analyzers (FDA Code:
GKP), Automated Coagulation Analyzer (FDA Code:
GKP), Fully Automated Random Access Coagulation Analyzer, Automated Coagulation Instrument (FDA Code:
GKP), Blood Clot Coagulation Analyzer (FDA Code:
GKP), Coagulation Analyzer with Timer (FDA Code:
GKP), ...
Organon Teknika B.V. manufactures HIV diagnostic products, including NucliSens® HIV-1 viral load and nucliSens HIV-1 RNA detection assays. Our product line includes nucleic acid sequence-based HIV
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FDA Code / Regulation: FIR / 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.