Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. Do not use with high-risk drugs, drugs with a narrow therapeutic range (catecholamines, morphine, 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. ) 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). Source: OMEDIT CENTRE -- Best practices for infusion:"Infusion flow accuracy" module.

Used materials 
PVC: Chamber, air intake, tubing - Polyethylene: cap with purge filter, protective cap for infusion set - synthetic polyisoprene: injection site - Acrylonitrile Butadiene Styrene: rotary flow regulator, infusion set, Mobile Luer Lock, fixed Luer Lock tip, body of injection site - Nylon: 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 : IIa
• MD notified body : 1370
• EU directive/regulation : 93/42/CEE-2007/47/CEE
• annexe : II

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
• Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.