LungFit® PH NDM Assembly

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 90014

by Beyond Air, Inc.

Identity

Trade Name: LungFit® PH NDM Assembly EUDAMED
LungFit PH NDM Assembly Kit FDA UDI
Generic Name: Nitric oxide delivery unit, system-based FDA UDI
Device Name: LungFit® PH NDM Assembly EUDAMED
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. FDA UDI
Model / Reference: 90014 EUDAMEDFDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: +B882900140+ EUDAMED
B882900140 FDA UDI
Basic UDI-DI: ++B88290014KB EUDAMED
PMA Number: P200044 FDA UDI
FDA Product Code: QTB FDA UDI
EMDN Code: Z1203019002 NITRIC OXIDE DISPENSERS EUDAMED
GMDN Term: Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class III FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

LungFit® PH NDM Assembly by Beyond Air, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++B88290014KB	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Beyond Air, Inc.
EUDAMED SRN: US-MF-000047279
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED 70e54789-5529-4578-b5be-b5bf7dbad0b2 61 fields · synced Sep 17, 2026
FDA UDI fc23c8bb-7477-4892-90d6-31e0d81f1c42 35 fields · synced May 30, 2026