LungFit PH NO2 Bagging Filter

Primary DI
B882900090
Brand
LungFit PH NO2 Bagging Filter
Company
Beyond Air, Inc.
Model
90009
Device description
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 bagging 48 hr NO2 filter p/n 90009).The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).The internal Bagging NO2 filter is the same basic design as the main NO2 filter that is inserted on the front of the device. The bagging NO2 filter’s useful life is 48 hours because the concentration of NO delivered through this filter is always 20 ppm at 10 L/min whereas up to 80ppm NO can be delivered through the main NO2 filter (or four times more than the backup system). The filter time remaining is tracked in the backup delivery microprocessors nonvolatile memory instead of on a RFID tag like the main NO2 Filter.
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
B882900091PackageHIBCC10In Commercial Distribution
B882900092PackageHIBCC12In Commercial Distribution
B882900090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA 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.

Contacts#

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

Regulatory Flags#

DUNS number
080243711
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
B882900020LungFit PH900022022-08-04
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
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
B882900020LungFit PHBeyond 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