EEC/93/42 Directive:
Medical Device, class IIa, sterile.
CE certificate n° 008 QPZ 149 issued to Axel S.r.l. by the notified body “Istituto Superiore della Sanità” (n° 0373). 
List of main components
Cannulae (stainless steel AISI 304);
Catheter (radiopaque FEP);
Catheter hub and Needle hub (polypropylene);
O-ring tubing fitting (acetylic resin);
Vent plug (polypropylene);
Luer lock cap and Valve cap (polypropylene);
Valve tubing (silicone rubber);
Catheter cap (polyethylene). 
Packing
Single blister (tyvek and plastic transparent film);
100 pcs. box and 1000 pcs. outer carton.  General information Sterilization by Ethylene Oxide gas.   Shelf life: 5 years. Storing Temperature: 5° 40° C.   Relative humidity: max. 80%.