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The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringe-based contrast injection systems included automatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded after the contrast media container has been deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.

The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast delivery systems (injectors). The BINJ Transfer Set is approximately 20 inches long, and its components are made with medical grade materials. The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6, and is individually packaged. At the time of this submission, accelerated aging tests confirm a one (1) year shelf life. The BINJ Transfer Set is disposable, and is to be discarded after the contrast media container has been depleted, or 10 hours has elapsed since the container was spiked.