4fb080a3-3f6b-433b-b9ea-699b847a8461UpdatePublished62023-09-072015-07-292021-12-10Not in Commercial Distribution04046963595104PrimaryGS1CELSITE54370255437025784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1CELSITE ST501G ST SET SIL 10F IV USAfalsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.com61494Vascular port/catheterA fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.trueActiveLJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULARDevice Size Text, specifySeptum Diameter : 12.000 MMCatheter GaugeSpecial Storage Condition, SpecifyKEEP DRYSpecial Storage Condition, SpecifyStore at room tempSpecial Storage Condition, SpecifyAvoid extreme temperatureSpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, Specifytruefalse