ExSpiron 2Xi

FDA UDI

Class II (US FDA UDI)

by Senzime AB (Publ.)

Identity

Trade Name: ExSpiron 2Xi FDA UDI
Generic Name: Monitoring spirometer, electrical FDA UDI
Device Name: A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system. FDA UDI
Model / Reference: RMI-54000 FDA UDI
Description: A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system. FDA UDI

Identifiers

Primary DI / UDI-DI: 00851540007147 FDA UDI
FDA Product Code: BZQ FDA UDI
BZK FDA UDI
GMDN Term: Monitoring spirometer, electrical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 FDA UDI
868.1850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Monitoring spirometer, electrical

ExSpiron 2Xi by Senzime AB (Publ.) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Senzime AB (Publ.)

Sources (1)

FDA UDI ec43e40b-7201-43eb-aada-df2ba4e71109 35 fields · synced Jun 8, 2026