Gas Sample Line with Nafion Tube Kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 90031

by Beyond Air, Inc.

Identity

Trade Name: Sample Line with Nafion Tube Kit FDA UDI
Generic Name: Nitric oxide delivery unit, system-based FDA UDI
Device Name: Gas Sample Line with Nafion Tube Kit EUDAMED
The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH. FDA UDI
Model / Reference: 90031 EUDAMEDFDA UDI
Description: The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH. FDA UDI

Identifiers

Primary DI / UDI-DI: +B882900310/ EUDAMED
B882900310 FDA UDI
Basic UDI-DI: ++B88290031KB EUDAMED
PMA Number: P200044 FDA UDI
FDA Product Code: QTB FDA UDI
EMDN Code: Z12030685 EUDAMED
GMDN Term: Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class: Class I EUDAMED
Class III FDA UDI
Medical Purpose: Gas sample line to withdraw gas from the ventilator breathing circuit tubing and carry it to the sample inlet of the device for monitoring. EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Gas Sample Line with Nafion Tube Kit by Beyond Air, Inc. — Class I — 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	++B88290031KB	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Beyond Air, Inc.
EUDAMED SRN: US-PR-000047709

Sources (2)

EUDAMED 70a2dbed-c719-4213-9356-e331de7b0210 61 fields · synced Jun 18, 2026
FDA UDI 0b1f5c3c-b108-4ebb-a972-98ed82de5497 35 fields · synced May 30, 2026