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The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container has been penetrated, whichever occurs first. Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

The Liebel-Flarsheim™ IBP Transfer Set is a sterile tubing set connection between Optiray® (Ioversol) contrast media imaging bulk packages (hereinafter Optiray IBPs) and empty sterile singleuse syringes on syringe-based automatic contrast injection systems. The Liebel- Flarsheim™ IBP Transfer Set consists of a small bore (1/8" ID) clear polyvinyl chloride (PVC) tube with standard medical component end terminations. Bonded to the proximal end of the PVC tube is a vented IV spike that is used to pierce a rubber stopper belonging to an imaging bulk contrast media container. Distally, a self-sealing Luer type connector (Smiths Medical Nu- Site®) is bonded to the opposite end of the PVC tube. The Liebel-Flarsheim™ IBP Transfer Set, shown in the image below, has an overall length of 19-inches, a protective cap on the IV Spike, and both untethered and tethered protective caps on the Luer end to protect the Nu-Site® Luer Activated fitting between syringe fills. The transfer sets are individually packaged in blister packs with a perimeter heat sealed Tyvek lid. Sealed blister packs are packaged in an outer box containing 50 units (50 units/box) which are terminally sterilized with ethylene oxide. The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.

The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures. The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.

The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.

The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.

The MEDRAD ® Imaging Bulk Package Transfer Set is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to a CT procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of iodinated contrast media only. Each imaging bulk transfer set consists of a spike, flexible tubing, and a swabbable valve. The transfer set is provided sterile, individually packaged, and is not intended to be resterilized.

The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.

The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

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.