LungFit PH Breathing Circuit 2 Kit

GUDID B882800120

Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached 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 breathing circuit just prior to inhalation by the patient, via a sampling line.

Beyond Air, Inc.

Nitric oxide delivery unit, system-based
Primary Device IDB882800120
NIH Device Record Keyef836b4e-ca23-4bad-9953-30763a0451c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungFit PH Breathing Circuit 2 Kit
Version Model Number80012
Company DUNS080243711
Company NameBeyond Air, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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.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
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
HIBCCB882800120 [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 Date2025-02-21
Device Publish Date2025-02-13

Devices Manufactured by Beyond Air, Inc.

B882800120 - LungFit PH Breathing Circuit 2 Kit2025-02-21Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached 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 breathing circuit just prior to inhalation by the patient, via a sampling line.
B882800120 - LungFit PH Breathing Circuit 2 Kit2025-02-21 Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The de
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 Filter2022-08-12 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

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