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LungFit PH

FDA PMAFDA UDI

Class III (US FDA PMA)

PMA P200044

by Beyond Air, Inc.

Identity

Trade Name
LungFit PH FDA PMAFDA UDI
Generic Name
Nitric Oxide Generator and Delivery System FDA PMA
Nitric oxide delivery unit, system-based FDA UDI
Device Name
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. FDA UDI
Model / Reference
90002 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B882900020 FDA UDI
PMA Number
P200044 FDA PMAFDA UDI
FDA Product Code
QTB FDA PMAFDA UDI
GMDN Term
Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class
Class III FDA PMAFDA UDI
Advisory Committee
Anesthesiology FDA PMA
FDA Decision
APPR Approved FDA PMA
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The LungFit PH is a Nitric Oxide Generator and Delivery System classified as a Class III medical device. It is designed to deliver a constant concentration of nitric oxide (NO) into the inspiratory limb of a patient’s ventilator circuit, improving oxygenation and reducing the need for extracorporeal membrane oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. The device integrates continuous monitoring of inspired oxygen (O₂), nitrogen dioxide (NO₂), and NO, alongside an integrated alarm system. It also features an independent backup NO delivery system capable of providing 1 L/min at 220 ppm NO to either a ventilator circuit or a bagging system.

The LungFit PH is intended for use in neonatal intensive care units (NICUs) and requires proper ventilation support alongside other therapeutic agents. Supplied as a reusable device, it is not sterile at shipment and must be cleaned and maintained according to manufacturer instructions. The system operates independently of MRI compatibility concerns and is authorized under FDA Premarket Approval (PMA) with PMA number P200044. Compliance with regulatory standards ensures safe and consistent NO delivery for clinical applications in term and near-term neonates.

Frequently asked questions

What clinical conditions is the LungFit PH designed to address in neonatal patients?

The LungFit PH is specifically designed to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term neonates (over 34 weeks gestation) suffering from hypoxic respiratory failure with pulmonary hypertension. It delivers nitric oxide (NO) to the inspiratory limb of a ventilator circuit, acting as a vasodilator to support respiratory function in these critically ill infants.

Is the LungFit PH a single-use or reusable device, and what maintenance is required?

The LungFit PH is a reusable device and is not sterile at shipment. It must be cleaned and maintained according to the manufacturer’s instructions to ensure proper function and safety. The device’s design allows for repeated use in neonatal intensive care units (NICUs) under proper care protocols.

How does the backup system on the LungFit PH differ from the primary nitric oxide delivery?

The backup system on the LungFit PH is an independent, secondary nitric oxide (NO) delivery mechanism that operates separately from the primary system. While the primary system delivers a user-set concentration of NO, the backup provides a fixed flow of 1 liter per minute at 220 parts per million (ppm) NO, which can be directed to either a ventilator circuit or a bagging system, ensuring continuous therapy if the primary system fails.

What types of monitoring and alarms does the LungFit PH include, and why are they important?

The LungFit PH integrates continuous monitoring of inspired oxygen (O₂), nitrogen dioxide (NO₂), and nitric oxide (NO) levels, alongside an integrated alarm system. These features are critical for ensuring safe and consistent NO delivery to neonates, as they allow clinicians to detect deviations in gas concentrations or system malfunctions in real time, reducing the risk of adverse events during treatment.

Can the LungFit PH be used with any ventilator, or are there specific compatibility requirements?

The LungFit PH is designed to integrate with a patient’s ventilator circuit, but compatibility depends on the ventilator’s inspiratory limb specifications. While the device itself is not MRI-compatible, its operation is independent of MRI concerns. Clinicians should verify ventilator compatibility with the manufacturer’s guidelines to ensure proper integration and safe use in neonatal intensive care settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Beyond Air, Inc.

Sources (2)

  • FDA PMA P200044 24 fields · synced Sep 18, 2026
  • FDA UDI dd24eec5-a1a9-4b5b-9e9e-e2862660d8c8 36 fields · synced May 27, 2026