ExSpiron 1Xi

Basic Information

• Brand Name: ExSpiron 1Xi
• Primary DI: 00851540007055
• Version / Model: Nurse Call Module
• Catalog Number: RMI-51155
• Company Name: Respiratory Motion Inc.
• Labeler DUNS: 963613745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-09-25
• Public Version Status: Update
• Public Device Record Key: 3d478747-5bda-40b1-83d4-b6c3c01f6a65

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	868.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62165	Nurse call system	An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851540007055	GS1
Package	00851540007079	GS1	Mixed Case	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 32 Degrees Celsius