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510(k) Data Aggregation

    K Number
    K151728
    Device Name
    CoStorSol plus G
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2015-09-18

    (84 days)

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

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
    Device Description
    Preservation Solutions, Inc. manufacturers CoStorSol® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds. CoStorSol® plus G is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.
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    K Number
    K091245
    Device Name
    COSTORSOL
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2009-06-17

    (50 days)

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

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
    Device Description
    Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, the cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, which must be chilled to between 2° and 6° C prior to use. The solution may be used without any point of use filtration.
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    K Number
    K083453
    Device Name
    COSTORSOL
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2009-01-21

    (61 days)

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

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient
    Device Description
    Preservation Solutions, Inc manufacturers CoStorSol® according to a "recipe" proneered at the University of Wisconsin by Dr Folkert O Belzer Indeed, the cold storage solution is often referred to as "Belzer UW" solution The formulation includes soluble collords, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to and tissue vrability by enabling regeneration of adenosine triphosphate (ATP) CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs The solution is packaged in 1-liter bags
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    K Number
    K080432
    Device Name
    MAPERSOL
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2008-08-08

    (171 days)

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

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.
    Device Description
    Preservation Solutions, Inc. manufacturers MaPerSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer and Dr. James Southard. The kidney flushing and perfusion storage solution may still be referred to as Belzer-MPS™, UW Machine Perfusion Solution, and is currently sold under that trade name (Trans-Med Corporation, Elk River, MN), as well as under the trade name KPS-1 (Organ Recovery Systems, Des Plaines, IL). The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). MaPerSol® is a colorless, sterile, non-toxic solution for in-vitro flushing and continuous perfusion of explanted kidnevs. The solution is packaged in 1-liter bags.
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    K Number
    K073693
    Device Name
    COSTORSOL
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2008-07-03

    (185 days)

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

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
    Device Description
    Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer. The cold storage solution is still referred to as "Belzer UW" solution, even though it has been marketed under the trade name ViaSpan®. The formulation includes soluble colloids, buffers, sodium and postassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP). CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags.
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    K Number
    K022826
    Device Name
    CLEAR-IT ANTI-FOG, MODEL PS003
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Date Cleared
    2002-10-09

    (44 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRESERVATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clear-It Anti-Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, microscope lenses, goggles and other devices that are likely to fog.
    Device Description
    Clear-It Anti-Fog is a solution whose primary ingredients are Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene proportionally mixed balanced and packaged according to approved manufacturing processes. Clear-It Anti-Fog is terminally sterilized by gamma irradiation. The appropriate dose was established using ISO 11137 method I protocol. Quarterly dose audits are performed using the same ISO 11137 protocol. Routine production testing prior to release includes pH, cytotoxicity, efficacy, and bacterial endotoxin.
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