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510(k) Data Aggregation

    K Number
    K220742
    Device Name
    NxtGen Infant Transport Incubator
    Manufacturer
    International Biomedical
    Date Cleared
    2022-07-15

    (123 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NextGen Transport Incubator is intended for use by personnel care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
    Device Description
    The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment for the infant during transport. The incubator is designed to maintain temperatures within desired limits as prescribed by the caregiver. The NxtGen Infant Transport Incubator has two modes of temperature control available – manual temperature mode and skin temperature control mode (or servo mode). The device includes several optional features including: integrated ambient oxygen monitor, integrated pulse oximeter, integrated phototherapy lighting, integrated electronic suction device, and an integrated heated mattress.
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    K Number
    K161918
    Device Name
    SREE MRI Transport Incubator
    Manufacturer
    ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS
    Date Cleared
    2017-03-03

    (233 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure. The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
    Device Description
    The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply. The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment. The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry. A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.
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    K Number
    K141565
    Device Name
    GLOBE-TROTTER GT5400
    Manufacturer
    Draeger Medical Systems, Inc.
    Date Cleared
    2014-09-10

    (90 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globe-Trotter GT5400 neonatal transport system is intended for the transport of newborns weighing up to 10 kg (22 lb) between healthcare facilities. It provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification, and ventilate with active humidification (optional). The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and is not intended for home use.
    Device Description
    The GT5400 is a combination of individual currently marketed medical devices without modification of their individual principles of operation. The GT5400 system is comprised of three main parts with standard and optional components. - o Transport Incubator - . Modular Frame - 0 Life Support Console (LCS). Variants - The GT5400 has two variants, Air Vehicle configuration (AV) and Ground Vehicle (GV) configuration.
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    K Number
    K123937
    Device Name
    ATOM TRANSCAPSULE V-707
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2013-05-23

    (154 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
    Device Description
    The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport. The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃. The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission. The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack. The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V). The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
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    K Number
    K103523
    Device Name
    185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Date Cleared
    2011-05-11

    (161 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
    Device Description
    The 185A+ Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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    K Number
    K103525
    Device Name
    A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Date Cleared
    2011-05-11

    (161 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
    Device Description
    The A750i Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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    K Number
    K103524
    Device Name
    VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Date Cleared
    2011-04-15

    (135 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
    Device Description
    The Voyager Infant Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors: infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc .; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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    K Number
    K103527
    Device Name
    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Date Cleared
    2011-04-15

    (135 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.
    Device Description
    The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer interes of a rece oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; axygen analyzers; air and oxygen cylinders; air compressors; etc. The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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    K Number
    K081399
    Device Name
    AVIATOR TRANSPORT INCUBATOR
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Date Cleared
    2008-06-06

    (18 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.
    Device Description
    Not Found
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    K Number
    K061071
    Device Name
    V-808 ATOM TRANSCAPSULE
    Manufacturer
    ATOM MEDICAL INC
    Date Cleared
    2006-08-29

    (134 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Product Code :

    FPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability. This device is not intended for home use. This is a prescription device.
    Device Description
    This product consists of a hood section, a mattress platform section, a middle deck section, a conditioning chamber section, an operation section and a pedestal section. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level, an oxygen supply function to deliver oxygen into the inner hood from outside, and a function to determine and display the oxygen concentration of the endosed compartment covered by the hood. It is further equipped with a function to measure and display the skin temperature of the neonate, as well as a pulse oximeter function to determine oxygen saturation and pulse rate non-invasively. It is a transport incubator, wherein said functions are intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low.
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