SPEAC System Electrode Patch-SPC15-90045, EU

Primary DI
B481SPC15900451
Brand
SPEAC System Electrode Patch-SPC15-90045, EU
Company
BRAIN SENTINEL, INC.
Model
SPC15
Catalog number
SPC15-90045
Device description
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory systemdesigned to monitor and analyze electromyography (EMG) data to detect the onsetof a generalized tonic-clonic (GTC) seizure whether primary or focal onset withsecondary generalization and to provide a warning signal to alert caregivers that aseizure is occurring. The system records EMG data (24/7) and is available for analysisof other motor events.The Brain Sentinel Seizure Detection and Warning System is intended for monitoringadults with a history or significant risk of generalized tonic-clonic seizures in thehome or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs,and for continuous monitoring, night time or any other time of day, of individuals dueto their history or risk of generalized tonic-clonic seizures and will withstand activitiesof daily living including showers and sleep. The Brain Sentinel Seizure Detection andWarning System is available by prescription only.
Published
2019-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
POSPhysiological Signal Based Seizure Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POSPhysiological Signal Based Seizure Monitoring SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B481SPC15900451PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home seizure monitoring systemAn assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
969967764
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B481SPC15900541AccuSense Sensitive Electrode Patch-SPC15-90054 USSPC15SPC15-90054 2019-11-07
B481SPC15900551AccuSense Sensitive Electrode Patch SPC15-90055 EUSPC15SPC15-900552019-11-07
B481SPC15900580SPEAC System Assy, Mini Monitor, EUSPC15SPC15-900582019-09-05
B481SPC15900180SPEAC System Electrode Patch SPC15-90018SPC15SPC15-900182019-09-04
B481SPC15900430SPEAC System Electrode Patch-SPC15-900431SPC15SPC15-900432019-09-04
B481SPC15900440SPEAC System Electrode Patch SPC15-90044, EUSPC15SPC15-900442019-09-04
B481SPC15900450SPEAC System Electrode Patch-SPC15-90045, EUSPC15SPC15-900452019-09-04
B481SPC15900570SPEAC System Assy, Mini Monitor, USSPC15SPC15-900572019-09-04
B481SPC15900441SPEAC System Electrode Patch SPC15-90044, EUSPC15SPC15-900442019-08-26
B481SPC15900181SPEAC System Electrode Patch SPC15-90018SPC15SPC15-900182019-08-13
B481SPC15900431SPEAC System Electrode Patch-SPC15-900431SPC15SPC15-9004312019-08-13
B481SPC15900571SPEAC System Assy, Mini Monitor, USSPC15SPC15-900572019-08-13
B481SPC150SPEAC SystemSPC152017-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00853858006379EpiMonitorEMPATICA SRLPOS2024-08-14
00853858006386EpiMonitorEMPATICA SRLPOS2024-08-14
00853858006102Embrace2EMPATICA SRLPOS2020-02-11
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00853858006133Embrace2EMPATICA SRLPOS2020-02-11
00853858006140Embrace2EMPATICA SRLPOS2020-02-11
B481SPC15900541AccuSense Sensitive Electrode Patch-SPC15-90054 USBRAIN SENTINEL, INC.POS2019-11-07
B481SPC15900551AccuSense Sensitive Electrode Patch SPC15-90055 EUBRAIN SENTINEL, INC.POS2019-11-07
B481SPC15900580SPEAC System Assy, Mini Monitor, EUBRAIN SENTINEL, INC.POS2019-09-05
B481SPC15900180SPEAC System Electrode Patch SPC15-90018BRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900430SPEAC System Electrode Patch-SPC15-900431BRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900440SPEAC System Electrode Patch SPC15-90044, EUBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900450SPEAC System Electrode Patch-SPC15-90045, EUBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900570SPEAC System Assy, Mini Monitor, USBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900441SPEAC System Electrode Patch SPC15-90044, EUBRAIN SENTINEL, INC.POS2019-08-26
B481SPC15900181SPEAC System Electrode Patch SPC15-90018BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900431SPEAC System Electrode Patch-SPC15-900431BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900571SPEAC System Assy, Mini Monitor, USBRAIN SENTINEL, INC.POS2019-08-13
08538580061026Embrace2EMPATICA SRLPOS2018-11-09
08538580061194Embrace2EMPATICA SRLPOS2018-11-09
08538580061262Embrace2EMPATICA SRLPOS2018-11-09
08538580061330Embrace2EMPATICA SRLPOS2018-11-09
08538580061408Embrace2EMPATICA SRLPOS2018-11-09
B481SPC150SPEAC SystemBRAIN SENTINEL, INC.POS2017-09-01