Indications 
This medical device is intended for the parenteral administration of injectable preparations (medications, nutrients). This device allows the precise administration by gravity of parenteral injectable preparations: drugs, solutions, parenteral nutrition. Do not use with high-risk medications, medications with a narrow therapeutic margin (catecholamines, opioids, heparin, insulin, potassium chloride, anticancer drugs requiring administration by infusion pump, and all pharmaceutical specialties which include in the SPC the need for administration by infusion pump or syringe pump.) Source: OMEDIT CENTER -- Good perfusion practices: “Precision of infusion rate” module.

Used materials 
Capuchon : PE Luer Lock femelle : PC Tube : PVC Régulateur de débit : ABS / TPE Site d'injection : ABS / Polyisoprène synthétique Luer Lock mâle : ABS Capuchon : PE

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

• MD class : IIa
• MD notified body : 0197
• EU directive/regulation : DIRECTIVE 93/42/CEE
• annexe : V

sterile 

• sterile : yes
• sterilization method : ethylene oxide

conformity 

• Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment