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U.S. FDA Medical Device Venturi Mask Requirements

FDA Medical Device Definition: A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

Registrar Corp assists Venturi Mask companies with:

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