LungFit PH Verification Kit

GUDID B882900151

Nitric oxide delivery system, secondary

Primary Device ID	B882900151
NIH Device Record Key	329b91d1-d0a7-4c85-8b6b-3b201a8c1d1b
Commercial Distribution Status	In Commercial Distribution
Brand Name	LungFit PH Verification Kit
Version Model Number	90015
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

Device Issuing Agency	Device ID
HIBCC	B882900150 [Primary]
HIBCC	B882900151 [Package] Contains: B882900150 Package: Box [5 Units] In Commercial Distribution
HIBCC	B882900152 [Package] Package: Box [6 Units] In Commercial Distribution

QTB	Nitric Oxide Generator And Delivery System

Steralize Prior To Use	false
Device Is Sterile	false

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B882800120 - LungFit PH Breathing Circuit 2 Kit	2025-02-21 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 - 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