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U.S. FDA Medical Device Anesthetic Tube Warmer Requirements


FDA Medical Device Definition: An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

Registrar Corp assists Anesthetic Tube Warmer companies with:

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