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Product Classification / EMDN Category

FDA Product Code: QTB

Directory of devices assigned to product classification code QTB.

classification Nitric Oxide Generator And Delivery System Manufacturer:
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gudid The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH. Manufacturer: Beyond Air, Inc.
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gudid 90017 is a kit containing two off-the-shelf components: -1: (61928) 22M-22F Straight Connector with 7.6 mm Port -2: (61921) Luer Elbow, fits 7.6 mm PortThe two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit. Manufacturer: Beyond Air, Inc.
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gudid The Luer elbow is a component to the gas sampling port which fits on a breathing circuit. Manufacturer: Beyond Air, Inc.
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gudid The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038). Manufacturer: Beyond Air, Inc.
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gudid The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only. Manufacturer: Beyond Air, Inc.
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gudid There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009).The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filters remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1m filters and two 5m filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).The internal Bagging NO2 filter is the same basic design as the main NO2 filter that is inserted on the front of the device. The bagging NO2 filters useful life is 48 hours because the concentration of NO delivered through this filter is always 20 ppm at 10 L/min whereas up to 80ppm NO can be delivered through the main NO2 filter (or four times more than the backup system). The filter time remaining is tracked in the backup delivery microprocessors nonvolatile memory instead of on a RFID tag like the main NO2 Filter. Manufacturer: Beyond Air, Inc.
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gudid There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009).The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filters remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1m filters and two 5m filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining). Manufacturer: Beyond Air, Inc.
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gudid 90007 is a kit containing two off-the-shelf components: -1: (61920) 15M-15F Straight Connector with 7.6 mm Port -2: (61921) Luer Elbow, fits 7.6 mm PortThe two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit. Manufacturer: Beyond Air, Inc.
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gudid 90006 is a kit containing two off-the-shelf components.-1: (61922) 10M-10F Straight Connector with 7.6 mm Port -2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit. Manufacturer: Beyond Air, Inc.
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gudid The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system.When the Selector Switch is turned to Bagging System position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient. Manufacturer: Beyond Air, Inc.
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gudid LungFit PH Product DescriptionThe LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line.The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System. Manufacturer: Beyond Air, Inc.
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gudid Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attachedbreathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line. Manufacturer: Beyond Air, Inc.
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gudid Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attachedbreathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line. Manufacturer: Beyond Air, Inc.
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gudid 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf).-1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The component is part of the LungFit PH verification kit. Manufacturer: Beyond Air, Inc.
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pma Nitric Oxide Generator and Delivery System Manufacturer: Beyond Air, Inc.
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