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510(k) Data Aggregation

    K Number
    K072921
    Device Name
    DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS, LLC
    Date Cleared
    2007-11-26

    (42 days)

    Product Code
    MEB, BSO, KGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYMBIOS MEDICAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.
    Device Description
    Not Found
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    K Number
    K071735
    Device Name
    MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS, LLC
    Date Cleared
    2007-07-19

    (23 days)

    Product Code
    MEB, BSO, KGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYMBIOS MEDICAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.
    Device Description
    The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
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    K Number
    K051474
    Device Name
    SYMBIOS DISPOSABLE INFUSION PUMP KIT
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS, LLC
    Date Cleared
    2005-07-01

    (28 days)

    Product Code
    MEB, BSO, KGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYMBIOS MEDICAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management. The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a proset rate for post-operative pain management.
    Device Description
    The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and a bandage. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
    Ask a Question

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