Each batch Mouse Embryo Assay (MEA) and
     LAL (Endotoxin Assay) tested
    Sterility conforming to EN 550 /
     biocompatibility conforming to ISO 10993
    EU Medical Device Classification: Class
     IIa/510(K) approval from the FDA
    Sets with single or double lumen needle
    Disposable, double sterile packed
    Echo marking 
    To be used by trained personnel only