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 Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary Nitric oxide delivery system, secondary
Primary Device IDB882900020
NIH Device Record Keydd24eec5-a1a9-4b5b-9e9e-e2862660d8c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungFit PH
Version Model Number90002
Company DUNS080243711
Company NameBeyond Air, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx
Phone1-855-586-4359
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 375 Millimeter of Mercury and 800 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB882900020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QTBNitric Oxide Generator And Delivery System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-12
Device Publish Date2022-08-04

Devices Manufactured by Beyond Air, Inc.

B882800112 - 22M-6mm Connector - Multipack2023-08-24 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The co
B882900020 - LungFit PH2022-08-12LungFit 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 PH2022-08-12 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 Kit2022-08-12 The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main
B882900061 - 10mm Gas Sample Adaptor2022-08-12 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 Kit2022-08-12 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 Filter2022-08-12 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
B882900091 - LungFit PH NO2 Bagging Filter2022-08-12 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
B882900141 - LungFit PH NDM Assembly Kit2022-08-12 The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric o

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