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U.S. FDA Medical Device Intravascular Administration Set Requirements: Intravascular Administration Set

FDA Medical Device Definition: An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container

Registrar Corp assists Intravascular Administration Set companies with:

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




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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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