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U.S. FDA Medical Device Hemodialysis System and Accessories Requirements: Hemodialysis System and Accessories

FDA Medical Device Definition: 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

Registrar Corp assists Hemodialysis System and Accessories companies with:

  • FDA Hemodialysis System and Accessories Establishment Registration
  • FDA Hemodialysis System and Accessories Listing
  • FDA Hemodialysis System and Accessories Label Requirements and Exceptions
  • FDA Hemodialysis System and Accessories Import Information
  • FDA Hemodialysis System and Accessories Detentions (Hemodialysis System and Accessories Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hemodialysis System and Accessories Manufacturers (Hemodialysis System and Accessories Suppliers)
       - Hemodialysis System and Accessories Distributors
       - Hemodialysis System and Accessories Processors
       - Hemodialysis System and Accessories Repackers
       - Hemodialysis System and Accessories Relabelers
       - Hemodialysis System and Accessories Exporters
       - Hemodialysis System and Accessories Importers
For more information about Hemodialysis System and Accessories Medical Devices, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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