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Prescribing Information

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1-855-LUNG-FLX or 1-855-586-4359

Unprecedented Speed to Care With iNO From Room Air1,2

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Innovative Ease of Care

Eliminate the hassle of cylinders or cassettes with the first and only 3-in-1 integrated system for inhaled nitric oxide (iNO) generation, delivery, and monitoring2

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Ready & Rapid iNO

Deliver iNO in seconds with patented Ionizer™ technology that generates unlimited, on-demand iNO from room air

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Optimal Operations

Reduce logistical and staffing burdens by eliminating the management, transport, and storage of large, pressurized iNO cylinders

LFPH Device

Unlimited, on-demand generation of iNO from room air, regardless of dose or flow.2

No cylinders, no cassettes, no hassle.

Request a Demo

Fast

Generate and deliver a preset iNO dose within seconds.1

Integrated auto-purging also saves clinicians time while reducing the risk of exposing patients to potentially high levels of NO2.3

Precise

The advanced Nitric Oxide Delivery Module provides precise and accurate real-time measurement of gas flow in the ventilator circuit to enable the LungFit® PH System to maintain accurate and stable iNO delivery.2

Simple

The key to the LungFit PH is the NO2 Smart Filter, which is only 2.5 oz and can be stored at the point-of-use location. This patient safety enhancement removes NO2 from the internal circuit and reduces patient and staff exposure. Each filter lasts 12 hours regardless of dose or flow.2

Experience iNO without cylinders or cassettes.

Complete the form below to schedule a demo

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References: 1. Data on file. Beyond Air Inc. 2021. 2. LungFit PH System Operator’s Manual. Garden City, NY: Beyond Air Inc. 2022. 3. Rimkus M, Bathe D, Montgomery F. On-demand nitric oxide for ventilator-based nitric oxide inhalation: a risk-reduction perspective. Abstracts of International Society for Aerosols in Medicine e.V. 22nd ISAM Congress, May 24, 2019, Montreux, Switzerland. J Aerosol Med Pulm Drug Deliv. 2019;32(3). https://doi.org/10.1089/jamp.2019.ab02.abstracts

Important Safety Information
INDICATIONS FOR USE

The nitric oxide from the LungFit PH System is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Refer to the full Prescribing Information within the LungFit PH System Operator’s Manual before use.

IMPORTANT SAFETY INFORMATION
  • The nitric oxide from the LungFit PH is contraindicated in neonates dependent on right-to-left shunting of blood.
  • Methemoglobin levels increase with the dose of nitric oxide; it can take 8 hours or more before steady-state methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of nitric oxide to optimize oxygenation.
DEVICE WARNINGS
  • Persons using the LungFit PH System should be trained and experienced in its use before performing procedures described in this manual to assure effective administration of nitric oxide and to avoid injury to the patient or to others resulting from inhalation of excess nitric oxide, nitrogen dioxide, or other reaction products.
  • Abrupt discontinuation of nitric oxide may lead to worsening oxygenation and increasing pulmonary artery pressure, ie., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate nitric oxide therapy immediately. 
  • A non-expired NO2 Filter must be properly installed at all times for the LungFit PH System to function. Always have at least 1 spare NO2 Filter available.
  • Do not make unauthorized changes to the device as it can result in harm to the patient.
CAUTION
  • To maintain the LungFit PH batteries in a charged state, keep the system plugged in between uses.
Rx Only

Consult the LungFit PH System Operator’s Manual for complete information. For technical support, call 1-855-586-4359.