ExSpiron 1Xi

FDA UDI

Class II (US FDA UDI)

by Respiratory Motion, Inc.

Identity

Trade Name: ExSpiron 1Xi FDA UDI
Generic Name: Nurse call system FDA UDI
Device Name: Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor. FDA UDI
Model / Reference: Nurse Call Module FDA UDI
Description: Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor. FDA UDI

Identifiers

Catalog Number: RMI-51155 FDA UDI
Primary DI / UDI-DI: 00851540007055 FDA UDI
FDA Product Code: BZQ FDA UDI
BZK FDA UDI
GMDN Term: Nurse call system 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nurse call system

ExSpiron 1Xi by Respiratory Motion, Inc. — 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: Respiratory Motion, Inc.

Sources (1)

FDA UDI 3d478747-5bda-40b1-83d4-b6c3c01f6a65 36 fields · synced May 30, 2026