Indications 
This medical device is intended for parenteral (subcutaneous, intravenous) administration of injectable preparations (drugs) by gravity or with a syringe pump (for small tube Ø). Pressure resistance: 4 bar

Used materials 
PVC: Tubing, female Luer lock tip - Polyethylene: Male Luer Lock cap and stopper, female Luer lock tip - Acrylonitrile Butadiene Styrene: Rotary flow controller, male and female Luer lock tip

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-