SPEAC System Electrode Patch SPC15-90044, EU
Basic Information
- Brand Name
- SPEAC System Electrode Patch SPC15-90044, EU
- Primary DI
- B481SPC15900440
- Version / Model
- SPC15
- Catalog Number
- SPC15-90044
- Company Name
- BRAIN SENTINEL, INC.
- Labeler DUNS
- 969967764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-04
- Public Version
- 1
- Public Version Date
- 2019-09-12
- Public Version Status
- New
- Public Device Record Key
- 1aa6f5c2-7b96-46d0-8880-f9b5788193bc
Device Description
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
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POS | Physiological Signal Based Seizure Monitoring System | Neurology | 882.1580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B481SPC15900440 | HIBCC |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 45 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius