LungFit PH Bagging Kit

GUDID B882900051

The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.

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 IDB882900051
NIH Device Record Key6d36abcb-c482-4fd6-b3ea-18f687a09897
Commercial Distribution StatusIn Commercial Distribution
Brand NameLungFit PH Bagging Kit
Version Model Number90005
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB882900050 [Primary]
HIBCCB882900051 [Package]
Contains: B882900050
Package: Box [5 Units]
In Commercial Distribution
HIBCCB882900052 [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 Kit2022-08-12The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
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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