Luer Elbow 7.6mm Port Kit

GUDID B882900161

The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.

Beyond Air, Inc.

Nitric oxide delivery system, secondary

• Primary Device ID: B882900161
• NIH Device Record Key: 460a0a0c-5439-41f8-b83e-c9ef5b70ccae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luer Elbow 7.6mm Port Kit
• Version Model Number: 90016
• 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	B882900160 [Primary]
HIBCC	B882900161 [Package]; Contains: B882900160; Package: Box [10 Units]; In Commercial Distribution
HIBCC	B882900162 [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: 2022-08-12 The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric o