Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum time the peripheral catheter can be in place). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol). Gravity infusion set, do not use for pressure infusion, transfusion or medicine that need a 0.2µm filter. Dispose according to the state member regulation.

Used materials 
PVC (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: Particle filter

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 : Is
• MD notified body : 2862
• EU directive/regulation : 2017/745
• annexe : IX Chapters I III

sterile 

• sterile : yes
• sterilization method : ethylene oxide

conformity 

• Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
• Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
• Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized medical devices;
• Medical devices - Part 1 : Application of usability engineering to medical devices
• Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management procee
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• Medical devices - Application of risk management to medical devices
• Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.