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510(k) Data Aggregation

    K Number
    K032154
    Device Name
    G-FREEZEKIT BLAST
    Manufacturer
    VITROLIFE AB
    Date Cleared
    2004-05-07

    (298 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Media for freezing of blastocyst stage embryos
    Device Description
    MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
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    K Number
    K032155
    Device Name
    G-THAWKIT BLAST
    Manufacturer
    VITROLIFE AB
    Date Cleared
    2004-05-07

    (298 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Media for thawing of blastocyst stage embryos
    Device Description
    MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.
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    K Number
    K022730
    Device Name
    PERFADEX SOLUTION FOR LUNG PRESERVATION
    Manufacturer
    VITROLIFE AB
    Date Cleared
    2003-10-27

    (437 days)

    Product Code
    MSB
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
    Device Description
    Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution. Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag. Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature. Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use. The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.
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    K Number
    K000619
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, G2.2
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-06-27

    (131 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000627
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-06-13

    (117 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000625
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, G1.2
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-05-23

    (96 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000626
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-05-23

    (96 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000618
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-05-17

    (90 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000621
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-05-16

    (89 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000623
    Device Name
    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
    Manufacturer
    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB
    Date Cleared
    2000-05-16

    (89 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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