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510(k) Data Aggregation

    K Number
    K053399
    Device Name
    VERSALET 7700 CARE CENTER
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Date Cleared
    2006-08-04

    (241 days)

    Product Code
    FMZ, FMT
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL INFANT CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. This device is not intended for home use.
    Device Description
    The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation through a convective air system with canopies and side panels forming an enclosure that isolates the air surrounding the infant from the room air, much the same as a traditional infant incubator. The Versalet™ 7700 Care Center offers access to the infant in the incubator mode by allowing the caregiver to open port holes or side panels. If more access is needed, the device can then be transitioned into a radiant warmer device by opening the canopies and raising the over head arm. This allows full access to the infant. The over head arm contains two infrared heaters that provide radiant heat only when the canopies are opened and the over head arm is fully raised. Thus the Versalet™ 7700 Care Center offers the caregiver excellent access while providing good thermal stability. While the device is in the transition mode from incubator to warmer there is a continued supply of convective heat to minimize the heat loss during this period.
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    K Number
    K042522
    Device Name
    JAUNDICE METER, MODEL JM 103
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Date Cleared
    2005-07-06

    (293 days)

    Product Code
    MQM
    Regulation Number
    862.1113
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL INFANT CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue as a shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor's offices under a physician's direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. The device is intended to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM-103 Jaundice Meter test results are indicative of hyperbilliubinemia should be evaluated by their physician(s) for appropriate patient management. JM-103 test results should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The JM 103 is a prescription Medical Device. The JM 103 is not intended for home use. The JM 103 may only be used at the sternum measurement site for Physician's office applications.
    Device Description
    The JM-103 Jaundice Meter is designed to provide a transcutaneous measurement of bilirubin displayed in Mg/dl or umol/L. This measurement is intended as a screening tool to determine when a serum bilirubin measurement should be taken, or, sequential bilirubin measurements over time to provide indication of change. This device is not intended for determinations of whether treatment is indicated. The determination of treatment must be based on a serum bilirubin measurement.
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