FDA.reportPublic FDA data

ExSpiron 1Xi

Primary DI
00851540007055
Brand
ExSpiron 1Xi
Company
Respiratory Motion Inc.
Model
Nurse Call Module
Catalog number
RMI-51155
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2
BZQMonitor, Breathing FrequencyAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851540007079PackageGS11In Commercial Distribution
00851540007055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851540007079008515400070798515400070790851540007079
00851540007055008515400070558515400070550851540007055

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7816097829support@respiratorymotion.com
2399204288info.us@senzime.com
800-213-1324info.us@senzime.com

Regulatory Flags#

DUNS number
963613745
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851540007000ExSpiron 1XiMonitorRMI-510002016-09-24
00851540007017ExSpiron Patient Cable, 8'RMI-511302016-09-24
00851540007024ExSpiron 1XiPower Cord, 10'RMI-512502016-09-24

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Primary DI, Brand, Company table
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00195278093998PORTRAIT HUB01GE Healthcare Finland OyBZQ2023-09-01
00195278094001PORTRAIT BCH01GE Healthcare Finland OyBZQ2023-09-01
00195278110435PORTRAIT MMP01GE Healthcare Finland OyBZQ2023-09-01
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