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510(k) Data Aggregation

    K Number
    K020966
    Device Name
    RPI REPLACEMENT HEATING ELEMENTS
    Date Cleared
    2002-06-13

    (80 days)

    Product Code
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPLACEMENT PARTS INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The heating elements are identical to those supplied as original equipment as part of the infant radiant warmer.
    Device Description
    The RPI Replacement Heating Elements are intended to be used as replacement parts for the Hill-Rom Air Shields infant radiant warmers. The RPI heating elements are used to emit infrared radiant heat in an infant radiant warmer to maintain an infant's body temperature. The Replacement Heating Elements are available in different outputs (wattage) and terminations. The heating elements are provided nonsterile.
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    K Number
    K021531
    Device Name
    RPI REPLACEMENT PHOTOTHERAPY LIGHTS
    Date Cleared
    2002-05-31

    (21 days)

    Product Code
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPLACEMENT PARTS INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use wi various phototherapy units and infant radiant warmers.
    Device Description
    The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hill-Rom Air Shields phototherapy units and infant radiant warmers. The replacement phototherapy lights are available in different wattage and other specifications. The lights are provided nonsterile.
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    K Number
    K020219
    Device Name
    RPI SKIN OR AIR TEMPERATURE PROBE
    Date Cleared
    2002-04-12

    (80 days)

    Product Code
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    REPLACEMENT PARTS INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.
    Device Description
    The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin or air temperature. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe. The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.
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