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510(k) Data Aggregation

    K Number
    K081345
    Device Name
    AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
    Manufacturer
    THERMOGENESIS CORP.
    Date Cleared
    2008-07-10

    (57 days)

    Product Code
    JQC
    Regulation Number
    862.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOGENESIS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow.
    Device Description
    The AXP Platform MarrowXpress System is a semi-automated, closed system that harvests a precise, operator-determined volume of stem cell-rich buffy coat from human bone marrow. The system consists of the following major components 1) disposable Processing Bag Set, 2) rechargeable NiMH battery-powered MXP Device, 3) AC-powered Docking Station, and 4) XpressTRAK software. Accessories include a bar code scanner, weight kit, counterweight, and MXP Device stand. The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow. The MXP Device separates the bone marrow aspirate into red blood cells, plasma, and buffy coat utilizing a standard laboratory centrifuge, and meters each of these components into a separate compartment within the disposable Processing Set. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. After processing, the MXP Device is placed into the AC powered Docking Station. The Docking Station automatically downloads processing data into the XpressTRAK software and recharges the MXP Device battery pack. The following information is communicated to the XpressTRAK software via a serial connection: MXP Device serial number, errors detected during processing, duration of processing, g force during processing, and mass calculation data. The XpressTRAK application software manages and stores the bone marrow processing data, verifies operational status of the system, and has report production capabilities. The software permits the user to search and sort collected data using the following fields: centrifuge ID, bone marrow aspirate unit number, Processing Bag Set lot number, buffy coat volume, user-definable fields, user name, or date and time.
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    K Number
    K071126
    Device Name
    CRYOSEAL FS APPLICATOR SYSTEM
    Manufacturer
    THERMOGENESIS CORP.
    Date Cleared
    2007-08-16

    (115 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOGENESIS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoSeal® FS Applicator System is intended for the simultaneous application of the two components of CryoSeal FS (fibrin sealant) onto the incised liver surface in patients undergoing liver resection.
    Device Description
    The CryoSeal® FS Applicator System is composed of a thermoplastic polystyrene applicator handle, and two types of dispensing tips with a Y-body manifolds for application of the fibrin sealant: line/drop tips (5 and 10 cm lengths) and spray tips (3 configurations).
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    K Number
    K955282
    Device Name
    THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
    Manufacturer
    THERMOGENESIS CORP.
    Date Cleared
    1996-05-06

    (172 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOGENESIS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThermoGenesis Applicators and Applicator Tips are intended to deliver two solutions simultaneously to a medical or surgical site This products are supplied sterile and are intended for single patient use.
    Device Description
    The ThermoGenesis Applicator product line consists of two devices: (1) a drop applicator with various straight, angled and flexible dual cannulated applicator tips, and (2) a spray application device with tip. All configurations of these products allow the user to deliver two solutions using one hand. All configurations of the devices are only intended for simultaneous application of two solutions and are specifically not intended for intravenous injection.
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