DEVICE: SPEAC System Electrode Patch-SPC15-90045, EU (B481SPC15900450)
Device Identifier (DI) Information
SPEAC System Electrode Patch-SPC15-90045, EU
SPC15
In Commercial Distribution
SPC15-90045
BRAIN SENTINEL, INC.
SPC15
In Commercial Distribution
SPC15-90045
BRAIN SENTINEL, INC.
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system
designed to monitor and analyze electromyography (EMG) data to detect the onset
of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with
secondary generalization and to provide a warning signal to alert caregivers that a
seizure is occurring. The system records EMG data (24/7) and is available for analysis
of other motor events.
The Brain Sentinel Seizure Detection and Warning System is intended for monitoring
adults with a history or significant risk of generalized tonic-clonic seizures in the
home 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 due
to their history or risk of generalized tonic-clonic seizures and will withstand activities
of daily living including showers and sleep. The Brain Sentinel Seizure Detection and
Warning System is available by prescription only.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61288 | Home seizure monitoring system |
An 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
POS | Physiological Signal Based Seizure Monitoring System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
Storage Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 5 and 35 Degrees Celsius |
Storage Environment Temperature: between 5 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e9469282-6f5f-4ce4-bde7-bbce0463e5fc
September 12, 2019
1
September 04, 2019
September 12, 2019
1
September 04, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined