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510(k) Data Aggregation

    K Number
    K083158
    Device Name
    EXALIS, SOFTWARE VERSION 1.15
    Manufacturer
    GAMBRO, INC.
    Date Cleared
    2009-06-05

    (224 days)

    Product Code
    KDI, 78K
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
    Device Description
    Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
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    K Number
    K070643
    Device Name
    PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
    Manufacturer
    GAMBRO, INC.
    Date Cleared
    2007-11-02

    (239 days)

    Product Code
    KDI, 78K
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
    Device Description
    Phoenix® is a self-contained, microprocessor-controlled device that provides hemodialysis and ultrafiltration-only therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. Phoenix® has a modular structure.
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    K Number
    K032431
    Device Name
    PRISMA M60/M100 SETS
    Manufacturer
    GAMBRO, INC.
    Date Cleared
    2003-09-15

    (40 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAMBRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.
    Device Description
    The Prisma Disposable Sets are sterile disposable extracorporeal circuits containing an AN 69 HF hemofilter/dialyzer and fluid circuit for use with the Prisma Control Unit. These Prisma Disposable Sets allow the following fluid management and renal replacement therapies to be performed: SCUF - Slow Continuous Ultrafiltration CVVH - Continuous Venovenous Hemofiltration CVVHD - Continuous Venovenous Hemodialysis CVVHDF - Continuous Venovenous Hemodiafiltration
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