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U.S. FDA Medical Device Vacuum Collection Bottle Requirements


FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Registrar Corp assists Vacuum Collection Bottle companies with:

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