Used materials 
PVC souple: Tubulure - Polypropylène: Bouchon du robinet - Polyéthylène: Clé du robinet, Bouchon et capuchon Luer Lock mâle - Polycarbonate: Corps du robinet - Acrylonitrile Butadiène Styrène: Embout Luer Lock mâle mobile et ?xe, corps site d’injection - Polyisoprène: Site d’injection.

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 9: Fluid lines for single use with pressure infusion equipment

economic operator 

• MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-