Federal Drug Administration 

The low-profile stabilization devices (G-Hug,GJ-Hug) are Class II exempt devices.

Product Classification

  • Code - PLI

  • Classification - Gastrointestinal Tube Holder

  • Reg Number - 876.5980

  • Class Device - 2

  • Submission Type - 510(k) Exempt

Refined Medical Solutions is not taking orders for products until regulatory requirements are met. Please contact us with any questions and rest assure we are focused in completing the appropriate measures to get these products to you as quickly and safely as possible.