Indications 
This product is designed to blend cytostatic drugs in a closed system. The blended infusion bag is delivered to the administration unit equipped with this line; all you have to do is connect the mobile LL to one of the branches of the administration line. At the end of infusion, leave all bypasses connected and put them all into the circuit for eliminating contaminated devices in Oncology

Used materials 
PVC DINCH: Tubing - Acrylonitrile Butadiene Styrene: Perforator, mobile Luer Lock - Polyethylene: protective cap for perforator - POM: clamp

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 : V

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

economic operator 

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

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