SPEAC System

GUDID B481SPC150

The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilit

BRAIN SENTINEL, INC.

Home seizure monitoring system

• Primary Device ID: B481SPC150
• NIH Device Record Key: 0474573a-b881-4f23-a4e6-885aacf49253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEAC System
• Version Model Number: SPC15
• Company DUNS: 969967764
• Company Name: BRAIN SENTINEL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B481SPC150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140033

FDA Product Code

• POS: Physiological Signal Based Seizure Monitoring System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-01

Devices Manufactured by BRAIN SENTINEL, INC.

• B481SPC15900541 - AccuSense Sensitive Electrode Patch-SPC15-90054 US: 2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromy
• B481SPC15900551 - AccuSense Sensitive Electrode Patch SPC15-90055 EU: 2019-11-15 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromy
• B481SPC15900580 - SPEAC System Assy, Mini Monitor, EU: 2019-09-13 The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surfa
• B481SPC150 - SPEAC System: 2018-07-06The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilit
• B481SPC150 - SPEAC System: 2018-07-06 The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home