Home GUDID B882900051 LungFit PH Bagging Kit
Primary DI B882900051
Brand LungFit PH Bagging Kit
Company Beyond Air, Inc.
Model 90005
Device description 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.
Published 2022-08-04
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QTB Nitric Oxide Generator And Delivery System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QTB Nitric Oxide Generator And Delivery System Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B882900051 Package HIBCC 5 In Commercial Distribution B882900052 Package HIBCC 12 In Commercial Distribution B882900050 Primary HIBCC 0
Regulatory Flags# DUNS number 080243711 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B882800130 LungFit PH Breathing Circuit 1 Kit 80013 2025-05-19 B882800120 LungFit PH Breathing Circuit 2 Kit 80012 2025-02-13 B882800111 22M-6mm Connector - Multipack 80011 2023-08-16 B882900050 LungFit PH Bagging Kit 90005 2022-08-04 B882900060 10mm Gas Sample Adaptor 90006 2022-08-04 B882900070 15mm Gas Sample Adaptor Kit 90007 2022-08-04 B882900080 LungFit PH NO2 Filter 90008 2022-08-04 B882900090 LungFit PH NO2 Bagging Filter 90009 2022-08-04 B882900140 LungFit PH NDM Assembly Kit 90014 2022-08-04 B882900150 LungFit PH Verification Kit 90015 2022-08-04 B882900160 Luer Elbow 7.6mm Port Kit 90016 2022-08-04 B882900170 22mm Gas Sample Adaptor Kit 90017 2022-08-04 B882900020 LungFit PH 90002 2022-08-04 B882900310 Sample Line with Nafion Tube Kit 90031 2022-08-04 B882800112 22M-6mm Connector - Multipack 80011 2023-08-16 B882900061 10mm Gas Sample Adaptor 90006 2022-08-04 B882900071 15mm Gas Sample Adaptor Kit 90007 2022-08-04 B882900081 LungFit PH NO2 Filter 90008 2022-08-04 B882900091 LungFit PH NO2 Bagging Filter 90009 2022-08-04 B882900141 LungFit PH NDM Assembly Kit 90014 2022-08-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B882800130 LungFit PH Breathing Circuit 1 Kit Beyond Air, Inc. QTB 2025-05-19 B882800120 LungFit PH Breathing Circuit 2 Kit Beyond Air, Inc. QTB 2025-02-13 B882800111 22M-6mm Connector - Multipack Beyond Air, Inc. QTB 2023-08-16 B882800112 22M-6mm Connector - Multipack Beyond Air, Inc. QTB 2023-08-16 B882900050 LungFit PH Bagging Kit Beyond Air, Inc. QTB 2022-08-04 B882900060 10mm Gas Sample Adaptor Beyond Air, Inc. QTB 2022-08-04 B882900070 15mm Gas Sample Adaptor Kit Beyond Air, Inc. QTB 2022-08-04 B882900080 LungFit PH NO2 Filter Beyond Air, Inc. QTB 2022-08-04 B882900090 LungFit PH NO2 Bagging Filter Beyond Air, Inc. QTB 2022-08-04 B882900140 LungFit PH NDM Assembly Kit Beyond Air, Inc. QTB 2022-08-04 B882900150 LungFit PH Verification Kit Beyond Air, Inc. QTB 2022-08-04 B882900160 Luer Elbow 7.6mm Port Kit Beyond Air, Inc. QTB 2022-08-04 B882900170 22mm Gas Sample Adaptor Kit Beyond Air, Inc. QTB 2022-08-04 B882900020 LungFit PH Beyond Air, Inc. QTB 2022-08-04 B882900061 10mm Gas Sample Adaptor Beyond Air, Inc. QTB 2022-08-04 B882900071 15mm Gas Sample Adaptor Kit Beyond Air, Inc. QTB 2022-08-04 B882900081 LungFit PH NO2 Filter Beyond Air, Inc. QTB 2022-08-04 B882900091 LungFit PH NO2 Bagging Filter Beyond Air, Inc. QTB 2022-08-04 B882900141 LungFit PH NDM Assembly Kit Beyond Air, Inc. QTB 2022-08-04 B882900151 LungFit PH Verification Kit Beyond Air, Inc. QTB 2022-08-04 B882900161 Luer Elbow 7.6mm Port Kit Beyond Air, Inc. QTB 2022-08-04 B882900171 22mm Gas Sample Adaptor Kit Beyond Air, Inc. QTB 2022-08-04 B882900310 Sample Line with Nafion Tube Kit Beyond Air, Inc. QTB 2022-08-04
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