DEVICE: LungFit PH (B882900020)
Device Identifier (DI) Information
LungFit PH
90002
In Commercial Distribution
Beyond Air, Inc.
90002
In Commercial Distribution
Beyond Air, Inc.
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37266 | Nitric oxide delivery unit, system-based |
A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QTB | Nitric Oxide Generator And Delivery System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P200044 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 375 and 800 Millimeter of Mercury |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
dd24eec5-a1a9-4b5b-9e9e-e2862660d8c8
February 14, 2025
2
August 04, 2022
February 14, 2025
2
August 04, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-855-586-4359
xxx@xx.xx
xxx@xx.xx