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510(k) Data Aggregation

    K Number
    K981169
    Device Name
    RONDEX CPR ISO-SHIELD
    Date Cleared
    1998-05-19

    (50 days)

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

    RONDEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim.
    Device Description
    The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child mouth-co-mouth vehiclate the operator's mouth from the victim's body fluids. The CPR ISO-SHIELD has a shield barrier, a plastic bite block/air tube with walve which is placed between the victim's teeth. The operator blows into the tube and uses victim's ceeth. The victim's exhalation is acceptable of their breath escaping around the valve and between the shield and their face. The large surface area of the barrier, 40 Square inides reduces the risk of vomitus coming in contact with the operator's face side of the shield. Two plastic grips are added to the ISO-SHIELD, attached to the valve housing below the barrier on the victim's side. This allows the operator to handle the device under the protective the operator of ize the transfer of contamination to the top surface. These grips also have memory which should help lift " surface. "Incoc getim's face after the operator releases his mouth. ISO-SHIELD has a polyethylene material. ISO-SHIELD uses a silicone rubber flapper design for the valve. This results in less valve. This is claires by the operator blowing into the valve as compared to Microshield. The ISO-SHIELD has two plastic grips attached to the valve housing.
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