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510(k) Data Aggregation

    K Number
    K193010
    Device Name
    Liebel-Flarsheim IBP Transfer Set
    Manufacturer
    Liebel-Flarsheim Company LLC
    Date Cleared
    2020-11-18

    (386 days)

    Product Code
    PQH
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liebel-Flarsheim Company LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K152361
    Device Name
    OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
    Manufacturer
    Liebel-Flarsheim Company LLC
    Date Cleared
    2016-01-14

    (147 days)

    Product Code
    IZQ
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liebel-Flarsheim Company LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.
    Device Description
    The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.
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