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510(k) Data Aggregation

    K Number
    K130324
    Device Name
    STATSEAL DISC
    Manufacturer
    BIOLIFE, LLC
    Date Cleared
    2013-07-09

    (151 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLIFE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns. Rx: StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
    Device Description
    Components - StatSeal Disc is composed of two main components: Potassium ferrate, and hydrophilic polymer. Mechanism of Action - StatSeal Disc achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.
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    K Number
    K080210
    Device Name
    PRO QR ADVANCED FORMULA POWDER
    Manufacturer
    BIOLIFE, LLC
    Date Cleared
    2009-02-10

    (379 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLIFE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. Rx: PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.
    Device Description
    Components - QR Powder is composed of two main components: potassium iron oxyacid salt, and a hydrophilic polymer. Mechanism of Action - QR Powder achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, QR Powder quickly forms a strong seal that completely covers the wound.
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    K Number
    K070520
    Device Name
    PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
    Manufacturer
    BIOLIFE, LLC
    Date Cleared
    2007-10-23

    (242 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLIFE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PRO QR Powder is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. It is intended to be distributed as a Professional Use (Non-Prescription) Device.
    Device Description
    Components - The PRO QR product is composed of two main components: potassium iron oxyacid salt and a hydrophilic polymer. Mechanism of Action - The PRO QR achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.
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