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510(k) Data Aggregation

    K Number
    K152809
    Device Name
    Giraffe Incubator Carestation CS1
    Manufacturer
    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
    Date Cleared
    2015-12-31

    (94 days)

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

    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
    Device Description
    The Giraffe Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator. The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.
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    K Number
    K122267
    Device Name
    GIRAFFE AND PANDA WARMERS
    Manufacturer
    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
    Date Cleared
    2012-10-02

    (64 days)

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

    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
    Device Description
    The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. Both units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and a UPS module, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.
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    K Number
    K101804
    Device Name
    GIRAFFE AND PANDA WARMERS
    Manufacturer
    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
    Date Cleared
    2010-07-21

    (23 days)

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

    OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
    Device Description
    The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. Both units also feature optional integrated SpO2 and Resuscitation Modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. The proposed modification of the Giraffe and Panda Warmers is the addition of the Giraffe Shuttle accessory. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers. The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories. The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The Shuttle contains two sensor systems: One system detects an interference condition. The other system determines the attaching status of the device. The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.
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