gudid
Primary ID: 90014
LungFit PH NDM Assembly Kit (UDI 90014)
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 NDM Assembly Kit - Primary ID 90014
Device Regulatory Overview
The LungFit PH NDM Assembly Kit (Model/Catalog Number: 90014) 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
- 90014
- Product Code / EMDN
- QTB
- Device Name
- 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.
- Database Sync Date
- 2026-08-09 09:06:21
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LungFit PH NDM Assembly Kit?
The registered manufacturer of record for LungFit PH NDM Assembly Kit is Beyond Air, Inc..
What is the Primary UDI-DI identifier for LungFit PH NDM Assembly Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 90014.
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.
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