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The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator. It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.

Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation. Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large. The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear. The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.

Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL ventilatiors are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

The ZOLL 731 Series Ventilators family consists of AEV, EMV+, Eagle II and Z Vent models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (≥ 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV) Positive Pressure Ventilation (PPV).

The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs). The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled. Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply. Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level. Ventilation is possible in both Invasive and Noninvasive settings. The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control. The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters. A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator. The electrical system is comprised of three primary boards: The main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU. the power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.

The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg. The RESPOND(R) Ventilator is intended for use in a hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.

The RESPOND® Ventilator is a multi-patient continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen/air to the breathing gas. The ventilator provides both pressure control and volume modes of therapy and can provide both invasive and non-invasive ventilation. The device is compatible with both passive HME and heated humidification patient circuits, as well as nebulization with an ultrasonic nebulizer. The ventilator is equipped with an oxygen mixing module, which allows oxygen to be delivered to the patient within a range of 21% to 95% concentration. The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. RESPOND® is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.) and is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND® Ventilator is intended for use by qualified and trained personnel.

FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency. For single patient use in the Hospital environment The mask is to be used on patients who are appropriate candidates for noninvasive ventilation. The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg

FAMILY OF DIMAR DIMAX NIV MASKS consists of two main types of a patient interface: - DIMAX ZERO - DIMAX The DIMAX ZERO MASK is a "total face" MASK that totally covers eyes, nose and mouth. The DIMAX ZERO MASK is provided for SINGLE USE. Below a short summary of the technical features of the DIMAX ZERO MASK: - The MASK can be connected to 2 different connectors: 1 for gas inlet and the other one for ● the exhaust gas outlet (the mask can also work with 1 connector, with the hole for the second connector - gas outlet- capped); - The MASK is fixed to the head of the patient through a 5 fixing points headgear; - A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks; - 2 specific luer ports are available for the control of the pressure through a manometer; - The DIMAX ZERO MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components: - 22F Non-Vented connector; O - 22F Vented connector with flop; O - 22F Non-Vented connector with FBS port; O - 22M-22M adapter; O - o 22F-22F adapter; - о 22F сар. The DIMAX MASK is a "Total Face" MASK that totally covers eyes, nose and mouth. The DIMAX MASK is provided for SINGLE USE. Below a short summary of the technical features of the DIMAX MASK: - The MASK can be connected through the same connector for both gas inlet and exhaust gas ● outlet; - The MASK is fixed to the head of the patient through a 5 fixing points headgear; - A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks; - 2 specific luer ports are available for the control of the pressure through a manometer; - The DIMAX MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components: - O 22F Non-Vented connector; - O 22F Vented connector with flop; - O 22F Non-Vented connector with FBS port.

The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask). - Assist/Control, SIMV, CPAP and NPPV modes of ventilation. The ventilator is suitable for use in institutional or transport settings.

The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start. Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues. The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.

The Sleepnet Mojo 2 and Veraseal 3 Full Face Non-Vented and AAV Non-Vented Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 -Single patient, multi-use (home or hospital/institutional)

The Sleepnet Mojo 2 and Veraseal 3 are full face mask used with non0invasive ventilation. They are available in multiple sizes and in a Non-Vented style with an elbow and Non-Vented with elbow and anti-asphyxia (AAV) valve. The subject of this submission is: - The Mojo 2 subject devices include a new contradiction and warning, which was not . included in the predicate device - K190533. Veraseal 3 is intended as a Disposable single use (hospital/institutional) and as a Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 is intended as a Single patient, multi-use (home or hospital/institutional)

The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.

The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.