AccessGUDID - DEVICE: SPEAC System Electrode Patch-SPC15-90045, EU (B481SPC15900451)

GUDID

Device Identifier (DI) Information

Brand Name: SPEAC System Electrode Patch-SPC15-90045, EU
Version or Model: SPC15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SPC15-90045
Company Name: BRAIN SENTINEL, INC.

Primary DI Number: B481SPC15900451
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969967764 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Humidity: between 45 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4fc2d0a9-957b-4b65-96a1-45a4c1a6ef2f
Public Version Date: September 03, 2019
Public Version Number: 1
DI Record Publish Date: August 26, 2019