FDA.reportPublic FDA data

LungFit PH

Primary DI
B882900020
Brand
LungFit PH
Company
Beyond Air, Inc.
Model
90002
Device description
LungFit PH Product DescriptionThe 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.
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTBNitric Oxide Generator And Delivery System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTBNitric Oxide Generator And Delivery SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200044000LungFit PHBeyond Air, Inc.2022-06-28QTB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B882900020PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure375 Millimeter of Mercury800 Millimeter of Mercury
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-586-4359xxx@xx.xx

Regulatory Flags#

DUNS number
080243711
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B882800130LungFit PH Breathing Circuit 1 Kit800132025-05-19
B882800120LungFit PH Breathing Circuit 2 Kit800122025-02-13
B88280011122M-6mm Connector - Multipack800112023-08-16
B882900050LungFit PH Bagging Kit900052022-08-04
B88290006010mm Gas Sample Adaptor900062022-08-04
B88290007015mm Gas Sample Adaptor Kit900072022-08-04
B882900080LungFit PH NO2 Filter900082022-08-04
B882900090LungFit PH NO2 Bagging Filter900092022-08-04
B882900140LungFit PH NDM Assembly Kit900142022-08-04
B882900150LungFit PH Verification Kit900152022-08-04
B882900160Luer Elbow 7.6mm Port Kit900162022-08-04
B88290017022mm Gas Sample Adaptor Kit900172022-08-04
B882900310Sample Line with Nafion Tube Kit900312022-08-04
B88280011222M-6mm Connector - Multipack800112023-08-16
B882900051LungFit PH Bagging Kit900052022-08-04
B88290006110mm Gas Sample Adaptor900062022-08-04
B88290007115mm Gas Sample Adaptor Kit900072022-08-04
B882900081LungFit PH NO2 Filter900082022-08-04
B882900091LungFit PH NO2 Bagging Filter900092022-08-04
B882900141LungFit PH NDM Assembly Kit900142022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B882800130LungFit PH Breathing Circuit 1 KitBeyond Air, Inc.QTB2025-05-19
B882800120LungFit PH Breathing Circuit 2 KitBeyond Air, Inc.QTB2025-02-13
B88280011122M-6mm Connector - MultipackBeyond Air, Inc.QTB2023-08-16
B88280011222M-6mm Connector - MultipackBeyond Air, Inc.QTB2023-08-16
B882900050LungFit PH Bagging KitBeyond Air, Inc.QTB2022-08-04
B88290006010mm Gas Sample AdaptorBeyond Air, Inc.QTB2022-08-04
B88290007015mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900080LungFit PH NO2 FilterBeyond Air, Inc.QTB2022-08-04
B882900090LungFit PH NO2 Bagging FilterBeyond Air, Inc.QTB2022-08-04
B882900140LungFit PH NDM Assembly KitBeyond Air, Inc.QTB2022-08-04
B882900150LungFit PH Verification KitBeyond Air, Inc.QTB2022-08-04
B882900160Luer Elbow 7.6mm Port KitBeyond Air, Inc.QTB2022-08-04
B88290017022mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900051LungFit PH Bagging KitBeyond Air, Inc.QTB2022-08-04
B88290006110mm Gas Sample AdaptorBeyond Air, Inc.QTB2022-08-04
B88290007115mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900081LungFit PH NO2 FilterBeyond Air, Inc.QTB2022-08-04
B882900091LungFit PH NO2 Bagging FilterBeyond Air, Inc.QTB2022-08-04
B882900141LungFit PH NDM Assembly KitBeyond Air, Inc.QTB2022-08-04
B882900151LungFit PH Verification KitBeyond Air, Inc.QTB2022-08-04
B882900161Luer Elbow 7.6mm Port KitBeyond Air, Inc.QTB2022-08-04
B88290017122mm Gas Sample Adaptor KitBeyond Air, Inc.QTB2022-08-04
B882900310Sample Line with Nafion Tube KitBeyond Air, Inc.QTB2022-08-04