LungFit PH

GUDID B882900020

LungFit PH Product Description The 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.

Beyond Air, Inc.

Nitric oxide delivery system, secondary

• Primary Device ID: B882900020
• NIH Device Record Key: dd24eec5-a1a9-4b5b-9e9e-e2862660d8c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungFit PH
• Version Model Number: 90002
• Company DUNS: 080243711
• Company Name: Beyond Air, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx
• Phone: 1-855-586-4359
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 375 Millimeter of Mercury and 800 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B882900020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200044

FDA Product Code

• QTB: Nitric Oxide Generator And Delivery System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-12
• Device Publish Date: 2022-08-04

Devices Manufactured by Beyond Air, Inc.

• B882800130 - LungFit PH Breathing Circuit 1 Kit: 2025-05-27 Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The de
• B882800120 - LungFit PH Breathing Circuit 2 Kit: 2025-02-21 Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The de
• B882800112 - 22M-6mm Connector - Multipack: 2023-08-24 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The co
• B882900020 - LungFit PH: 2022-08-12LungFit PH Product Description The 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.
• B882900020 - LungFit PH: 2022-08-12 LungFit PH Product Description The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical v
• B882900051 - LungFit PH Bagging Kit: 2022-08-12 The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main
• B882900061 - 10mm Gas Sample Adaptor: 2022-08-12 90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) L
• B882900071 - 15mm Gas Sample Adaptor Kit: 2022-08-12 90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921)
• B882900081 - LungFit PH NO2 Filter: 2022-08-12 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 bag