LungFit PH Verification Kit

Basic Information

• Brand Name: LungFit PH Verification Kit
• Primary DI: B882900150
• Version / Model: 90015
• Company Name: Beyond Air, Inc.
• Labeler DUNS: 080243711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-04
• Public Version: 2
• Public Version Date: 2025-02-14
• Public Version Status: Update
• Public Device Record Key: 329b91d1-d0a7-4c85-8b6b-3b201a8c1d1b

Device Description

The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QTB	Nitric Oxide Generator And Delivery System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
37266	Nitric oxide delivery unit, system-based	A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B882900151	HIBCC	Box	5	In Commercial Distribution
Primary	B882900150	HIBCC
Package	B882900152	HIBCC	Box	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P200044	000