LungFit PH NDM Assembly Kit

GUDID B882900141

The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only.

Beyond Air, Inc.

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• Primary Device ID: B882900141
• NIH Device Record Key: fc23c8bb-7477-4892-90d6-31e0d81f1c42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungFit PH NDM Assembly Kit
• Version Model Number: 90014
• Company DUNS: 080243711
• Company Name: Beyond Air, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx
• Phone: 1-855-586-4359
• Email: xxx@xx.xxx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B882900140 [Primary]
HIBCC	B882900141 [Package]; Contains: B882900140; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B882900142 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200044

FDA Product Code

• QTB: Nitric Oxide Generator And Delivery System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-12
• Device Publish Date: 2022-08-04

Devices Manufactured by Beyond Air, Inc.

• B882800112 - 22M-6mm Connector - Multipack: 2023-08-24 80011 is a multipack of 20 oxygen stem connectors (off-the-shelf). - 1: (61911) Connector, Straight, 22M-6mm Oxygen Stem The co
• B882900020 - LungFit PH: 2022-08-12 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 Kit: 2022-08-12 The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main
• B882900061 - 10mm Gas Sample Adaptor: 2022-08-12 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 Kit: 2022-08-12 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 Filter: 2022-08-12 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 Filter: 2022-08-12 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 Kit: 2022-08-12The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only.
• B882900141 - LungFit PH NDM Assembly Kit: 2022-08-12 The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric o