FDA.reportPublic FDA data

ExSpiron 2Xi

Primary DI
00851540007147
Brand
ExSpiron 2Xi
Company
Senzime AB (Publ.)
Model
RMI-54000
Device 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.
Published
2020-01-06
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192595000ExSpiron 2XiRespiratory Motion2019-12-17BZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851540007154PackageGS11In Commercial Distribution
00851540007147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851540007154008515400071548515400071540851540007154
00851540007147008515400071478515400071470851540007147

GMDN Terms#

Term, Definition table
TermDefinition
Monitoring spirometer, electricalA mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal101 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius32 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal101 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
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
559976316
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350012440268TetraHubSEN 2017SEN 20172024-10-11
07350012440237TetraGraphSEN 2015 TetraGraph monitorSEN 20152024-10-03
07350012440022TetraSensTetraSensSEN 20022020-04-23
07350012440121TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440169TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440183TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440244TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
00851540007161ExSpiron Pediatric PadSetsPediatricRMI-530402024-01-25
07350012440206TetraSensitiveSEN 2014 TetraSensitiveSEN 20142023-11-06
07350012440107TetraGraph Philips InterfaceTetraGraph Philips InterfaceSEN 20072022-09-07
07350012440145TetraGraph XcomSEN 2010 TetraGraph XcomSEN 20102022-09-07
07350012440015TetraGraphSEN 2001 TetraGraph monitorSEN 20012020-04-23
07350012440091TetraGraph Pole Clamp kitSEN 2101 Pole Clamp for TetraGraph (Optional)SEN 21012020-04-23
00851540007048ExSpiron PadSetsAdultRMI-511102016-09-24
07350012440176TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440190TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440251TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
07350012440114TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440039TetraSensTetraSensSEN 20022020-04-23

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