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510(k) Data Aggregation

    K Number
    K960587
    Device Name
    CPROTECTOR 2000
    Date Cleared
    1997-07-21

    (525 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERTIFIED SAFETY MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A physical barrier for mouth to mouth resuscitation between the victim (patient) and the rescuer. This device makes no "guarantee" of disease protection, but it is designed to help protect the rescuer against potentially contaminated secretions and back drafts emanating from the victim while eliminating actual mouth to mouth contact. This device is to be used only by persons trained in CPR and the use of this device. DO NOT USE THIS DEVICE ON INFANTS.
    Device Description
    The CPRotector 2000 device is a mouth-to-mouth barrier that offers protection to the CPR administrator from vomitus and other oral secretions. It is to be used only by persons trained in the application of CPR. Each CPRotector 2000 comes prepackaged with complete instructions for use. It is labeled as a single-use device and therefore must be disposed of after each use, in accordance with applicable rules and requlations. The CPRotector 2000 includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directs the exhaled gases away from the rescuer and into the atmosphere. The components used in the manufacture of this device are made from PVC compounds which have been tested to meet the requirements of USP XXII, 1990, and Supplement 5, 1991, for the Biological Test for Plastics, Class VI-70°C.
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    K Number
    K960615
    Device Name
    GAUZE COMPRESS
    Date Cleared
    1996-11-25

    (286 days)

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

    CERTIFIED SAFETY MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K960624
    Device Name
    CERTI COOL INSTANT COLD COMPRESS
    Date Cleared
    1996-05-06

    (83 days)

    Product Code
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERTIFIED SAFETY MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.
    Device Description
    The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.
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