gudid
Primary ID: 90002
LungFit PH (UDI 90002)
Manufactured by Beyond Air, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LungFit PH - Primary ID 90002
Device Regulatory Overview
The LungFit PH (Model/Catalog Number: 90002) is a medical device manufactured by Beyond Air, Inc.. This product is indexed under FDA Product Code / Category Classification QTB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 90002
- Product Code / EMDN
- QTB
- Device Name
- LungFit PH Product DescriptionThe LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line.The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
- Database Sync Date
- 2026-08-09 09:06:21
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LungFit PH?
The registered manufacturer of record for LungFit PH is Beyond Air, Inc..
What is the Primary UDI-DI identifier for LungFit PH?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 90002.
What classification code is assigned to this device?
This device is registered under product classification code QTB.
Similar Classification Devices (QTB)
Other Devices by Beyond Air, Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint