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VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows short-term ventilation with humidified breathing gas and additional PEEP. It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb). VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP. The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

The subject devices, VentStar Autobreath heated (N) (MP17031) and VentStar Resus heated (N) (MP17030), are two heated disposable single limp breathing circuits with humidifier chamber for connection to the humidifier MR850 by Fisher and Paykel (K073706), for neonatal patients with a maximum body weight of 10 kg for use with the Dräger BabyRoo TN300 (K230278) and Dräger Resuscitaire (K120642). The VentStar Resus heated (N) MP17030 is equipped with a manual PEEP valve which enables the setting of a PEEP by the operator directly. The operator can control the inhalation and exhalation. The VentStar Autobreath heated (N) MP17031 is equipped with an automatic PEEP valve. With the Autobreath function a respiratory rate can be adjusted on the resuscitation module and a machine controlled consistent inspiration rate can be applied to the patient. The heated breathing circuits are intended for conveying breathing gases (air and/or oxygen) from a breathing gas source (resuscitation module) to the humidifier chamber and finally to the patient. Both breathing circuits are designed for a flow range from 5 to 15 L/min. The heating of the hoses is done by using electrical heating wires inside the wall of the hoses. These wires have specific electrical resistances to generate a specific heating power. The heating plate of the humidifier chamber is positioned at the heater of the humidifier.

VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient. VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.

The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators. Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.

The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.

The intensive care ventilators Evita V800 and Evita V600 were developed and are manufactured by Dräger in Lübeck, Germany. Evita V800 and Evita V600 are specified for the ventilation of adults, pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. Evita V800 and Evita V600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories. Evita V800 and Evita V600 are available with a basic device configuration that comprises the following: Trolley with four castors and brakes, Display unit (graphical user interface), Ventilation unit. The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.

The Babylog intensive care Ventilator (Babylog VN600) is intended for the ventilation of neonates with a body weight of 0.4 kg (0.88 lb) to 10 kg (22 lb) and for pediatric patients with an IBW of 5.2 kg (11.5 lb) to 20.1 kg (44.3 lb). This device provides mandatory pressure-controlled ventilation modes for supporting spontaneous breathing, and ventilation monitoring.

The intensive care ventilators Babylog VN800 and Babylog VN600 were developed and are manufactured by Dräger in Lübeck, Germany. Babylog VN800 and Babylog VN600 are specified for the ventilation of pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. Babylog VN800 and Babylog VN600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories. Babylog VN800 and Babylog VN600 are available with a basic device configuration that comprises the following: - Trolley with four castors and brakes - Display unit (graphical user interface) - Ventilation unit The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.

Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor). Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.

The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface. The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer. Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates. The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

The Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel. The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals. The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas. Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

The Infinity Acute Care System Workstation Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.