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.
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.
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