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510(k) Data Aggregation
(132 days)
The DeVilbiss 5 Liter (555) Oxygen Concentrator is intended to provide supplemental oxygen to adult patients requiring oxygen therapy. The device may be used in the home or an institutional setting. The device is not intended to be life sustaining or life supporting.
The DeVilbiss 5-Liter (555) Oxygen Concentrator (hereafter referred to as "555") is a portable device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen through a pressure swing adsorption process, allowing oxygen to be delivered at a range of prescribed flows to patients in need of supplemental oxygen.
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(176 days)
The Hudson RCI® Infant Dri-Tech™ Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in a professional healthcare environment as a conduit for warmed and humidified respiratory gases between a patient and a ventilator and includes heated wires for use with the Hudson RCI Neptune Heated Humidifier.
The Hudson RCI® Infant Dri-Tech Breathing Circuits are intended for neonatal, infant, and pediatric patients weighing 32kg or less in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator and includes heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier (K131912). The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
The Dri-Tech Infant Breathing Circuits are designed to be used with various patient interfaces such as oral tracheal tubes, nasal tracheal tubes, endo-bronchial tubes, and masks (for noninvasive ventilation therapies such as CPAP, BiPAP, Cannula and Mask usage). As such, Dri-Tech Breathing Circuits are designed and will be manufactured to conform to the test requirements of ISO 5367:2014 "Anaesthetic and respiratory equipment -- Breathing sets and connectors".
The dual limb configuration consists of 12mm ID inspiratory and expiratory limbs with 22mm machine side connectors that are compliant to ISO 5356-1:2015 Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets, and 12mm patient side connectors that utilize the same taper and engagement length as ISO 5356-1:2015 connectors. The infant circuits have two length configurations, a short inspiratory that is 1.12m or a long inspiratory that is 1.6m, either of which can be used with an expiratory limb that is 1.7m, and may be kitted with the accessories described below:
- Accessory Tee with Closure Cap: Optional tubing adaptor for various connections as required.
- Remote Port Tubing, 6" and 12": Unheated sections of tubing for use with incubators, isolettes, or other ambient heating to ensure the temperature probe is not heated by the environment.
- Unheated Ventilator Tubing: Required tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
The single limb configuration is identical to the long version of the inspiratory limb of the dual limb configuration, however, is packaged with a different set of adaptors to facilitate connections and use with non-invasive therapies as described below:
- Unheated Ventilator Tubing: Optional tubing and adaptors for connecting the ventilator inhalation port to the heated humidifier.
- Pressure Monitoring Line: Optional accessory tubing for use with units without an Airway Pressure Monitor.
All Hudson RCI Dri-Tech breathing circuit configurations are packaged in polyethylene (PE) bags to protect the devices from environmental influences like dust and moisture. Included in the PE bags are additional PE bags containing ConchaSmart columns (-KIT configurations only) and included accessories. The breathing circuit PE bags are packaged ten (10) to a cardboard carton for all configurations. They are sold non-sterile.
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(268 days)
The Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocker Tube is indicated for pediatric populations, in children with minimum 10 Kg of weight. All other sizes are for adult use only.
The Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. Widely used in combination with various endotracheal tubes, it doesn't require re-intubation at the conclusion of surgery as with a double-lumen endotracheal tube. Doctor can easily move the blocker from one side to the other and place the cuff on the target airway accurately by rotating the outside tube. The angled tip lets the blocker easily enter any bronchus and adjust position. Aspiration of secreted material can be done via the suction port. The auto inflator can be operated with one hand to the cuff.
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(258 days)
The BreathePal Bilevel is intended to provide non-invasive ventilator (NIV) support for adult patients weighing over 30 kg (66lbs) who suffer from Obstructive Sleep Apnea (OSA) and Respiratory Impairment. It is intended for use in both home and clinical environment, including hospitals, sleep laboratories, and sub-acute care institutions.
BreathePal Bilevel devices are blower-based positive airway pressure systems designed to provide non-invasive ventilation only. These devices deliver two distinct pressure levels: a higher pressure during inhalation (IPAP) and a lower pressure during exhalation (EPAP). This pressure differential facilitates the flow of air into and out of the lungs. The system can also be configured to provide a single, constant pressure level, known as Continuous Positive Airway Pressure (CPAP).
The BreathePal Bilevel utilizes a microprocessor-controlled blower along with integrated pressure and flow sensors to detect patient breathing patterns and deliver precise therapeutic pressure. The device includes a comprehensive alarm system, featuring both therapeutic alerts (e.g., large leak) and technical alarms (e.g., system fault). A user interface allows for the adjustment of clinical parameters and the display of monitored therapy data. Additionally, the device features comfort settings, such as iBreath (FLEX), which provides adaptive pressure relief during the initial phase of exhalation to enhance patient comfort.
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(86 days)
The LungFlow Basket Catheter is intended to be used to endoscopically remove foreign bodies from the airway.
The Free Flow Medical LungFlow Basket Catheter is a sterile, single use disposable foreign body retrieval device. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable removal of foreign bodies which include inhaled objects or material, incidental medical debris, mucus, necrotic or potentially infective tissue or excised tissue from the airway, as the device is retracted proximally.
The LungFlow Basket Catheter consists of a flexible coiled stainless steel wire trunk with a multi-wire 360-degree super-elastic nitinol basket at the distal end. The LungFlow Basket Catheter is designed to be delivered through the working channel (2.0mm and 2.8mm or larger) of an endoscope, such as a rigid or flexible bronchoscope.
The LungFlow Basket Catheter is provided in configurations with a handle to manually assist the distal basket expansion or with a self-expanding distal basket.
The LungFlow Basket Catheter may be delivered into distal lung airways using a compatible airway catheter if the catheter has been advanced through a therapeutic bronchoscope and into lung tissue with guidance provided by bronchoscope. Both manual expansion and self-expanding configurations are intended to be delivered distal to a foreign body before expansion. The LungFlow Basket Catheter will be provided in configurations that can expand up to 30mm in diameter. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable reliable removal of foreign bodies from the airway.
Each LungFlow Basket Catheter is individually packaged and sterilized using electron beam (e-beam) radiation.
The LungFlow Basket Catheter is manufactured in the United States.
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(265 days)
The 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 or respiratory insufficiency.
The mask is for single patient use in the hospital/institutional environment only.
The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
The VPAP Pediatric Face Mask is designed for pediatric patients in hospital and institutional settings, serving as an interface for Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure (BiPAP) therapy. Available in two sizes to accommodate varying facial dimensions of pediatric patients, these masks ensure a comfortable and secure fit. The VPAP Pediatric Face Mask is intended for single-patient, supporting consistent and reliable noninvasive ventilation.
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(293 days)
The AirICU Max+ is a portable medical device for single patients use. It is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. It is suitable for adults (≥22 year old) who require nebulization therapy.
Medical Mesh Nebulizer (AirICU Max+) is a portable medical device for single patients use.
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(265 days)
The MESI mTABLET SPIRO is indicated for use to conduct assessment of respiratory function by way of measurement of dynamic lung volumes (also known as spirometry) on adult and pediatric patients, ages 5 years and older. The device measures patient respiratory parameters including FVC, FEV1, FEV6, and VC. MESI mTABLET SPIRO is intended to be operated by medical professionals in health care environments including primary care facilities, hospitals and health centers.
The MESI mTABLET SPIRO is an automated wireless spirometer device for diagnosing and screening patients with respiratory diseases. The system is intended to perform, view and store spirometry measurements of adult and pediatric patients. It is comprised of a wireless tablet, spirometer module, disposable mouthpieces and charging station module.
The MESI mTABLET SPIRO is intended to be used in a professional clinical environment by trained healthcare personnel who understand the principle of spirometry measurements, can demonstrate the measurement procedure, verify that the system is working as intended, and start the measuring process.
The MESI mTABLET SPIRO works on pneumotach principle that relies on the airflow measurement according to the pressure difference that occurs when a flowing fluid is forced through a narrow section (disposable mouthpiece), resulting in a pressure decrease and a velocity increase, which is also known as the Venturi Effect. Values measured are indirectly calculated from the measured airflow. Spirometry parameters are captured and displayed as a numerical and graphical representation on MESI mTABLET UNIT.
The device is recharged through the AC/DC power supply. The MESI mTABLET SPIRO is not intended to be used while connected to mains electricity.
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(207 days)
The AViTA Pulse Oximeter is intended for spot check monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults, adolescents and child in home and professional healthcare facility settings. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches ~0.9 inches) and intended for use during no-motion condition. The device is prescription only
The AViTA Pulse Oximeter is a non-invasive, prescription-use medical device intended for spot-check monitoring measurement of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate in adult, adolescent, and child users in home and professional healthcare environment settings.
The device operates using spectrophotometry by emitting red and infrared light through a pulsatile vascular bed, such as a fingertip, and detecting the light transmitted through the tissue to determine the relative concentrations of oxygenated and deoxygenated hemoglobin.
The device is designed for use on fingers with a thickness range of approximately 0.8 cm to 2.3 cm (0.3 inches to 0.9 inches) and is intended for use under no-motion conditions. The device is intended for spot-check measurements only and is not intended for continuous monitoring.
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(269 days)
The Mariana Minerva is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
The Mariana Nimbus is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
The Mariana devices, that is Mariana Minerva and Mariana Nimbus, are non-invasive ventilation (NIV) devices that use a microprocessor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. They have an integrated alarms module. The Mariana devices also include optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The devices provide both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The devices use an external AC power supply and allow the addition of low pressure supplemental oxygen.
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