LungFit PH NO2 Filter

GUDID B882900081

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).

Beyond Air, Inc.

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Primary Device IDB882900081
NIH Device Record Key8011dee7-6f57-49fb-9467-7bb22a34437c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungFit PH NO2 Filter
Version Model Number90008
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx
Phone1-855-586-4359
Emailxxx@xx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB882900080 [Primary]
HIBCCB882900081 [Package]
Contains: B882900080
Package: Box [10 Units]
In Commercial Distribution
HIBCCB882900082 [Package]
Package: Box [12 Units]
In Commercial Distribution

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 PH2022-08-12 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 Filter2022-08-12There 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).
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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