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U.S. FDA Medical Device Reservoir Bag Requirements

FDA Medical Device Definition: A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

Registrar Corp assists Reservoir Bag companies with:

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

U.S. FDA Regulations:

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

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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