ExSpiron PadSets

FDA UDI

Class II (US FDA UDI)

by Senzime AB (Publ.)

Identity

Trade Name: ExSpiron PadSets FDA UDI
Generic Name: Monitoring spirometer, electrical FDA UDI
Device Name: A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity. FDA UDI
Model / Reference: Adult FDA UDI
Description: A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity. FDA UDI

Identifiers

Catalog Number: RMI-51110 FDA UDI
Primary DI / UDI-DI: 00851540007048 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Monitoring spirometer, electrical

ExSpiron PadSets 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 e716bb64-c9f8-47da-8833-8c093acc0da5 36 fields · synced May 30, 2026