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U.S. FDA Medical Device Rectal Catheter Requirements

FDA Medical Device Definition: A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Registrar Corp assists Rectal Catheter companies with:

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