Sleep Profiler

GUDID 00851113007017

Sleep Profiler Desktop Software

ADVANCED BRAIN MONITORING, INC.

Polysomnography analyser

• Primary Device ID: 00851113007017
• NIH Device Record Key: f4001074-678a-446c-b3ce-f3822402cb87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleep Profiler
• Version Model Number: Sleep Profiler Desktop Software
• Company DUNS: 969842715
• Company Name: ADVANCED BRAIN MONITORING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851113007017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120450

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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: 2016-09-23

On-Brand Devices [Sleep Profiler]

• 00851113007741: Sleep Profiler System Kit - TRL
• 00851113007154: Sleep Profiler Device Kit
• 00851113007253: 50-Night Study Kit - Sleep Profiler ICU
• 00851113007239: 50-Night Study Kit - Sleep Profiler
• 10851113007229: Sleep Profiler Strip Kit
• 20851113007219: Sleep Profiler Headband Kit
• 00851113007024: Sleep Profiler Portal Software
• 00851113007017: Sleep Profiler Desktop Software
• 10851113007007: Adult General Purpose Electrodes
• 00851113007949: Sleep Profiler LE Device Kit
• 00850015266522: Sleep Profiler LE Device Kit Italian
• 00850015266539: Sleep Profiler LE Device Kit German
• 00850015266225: Sleep Profiler Device Kit (No sensors)
• 00850015266607: Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
• 00850015266591: Sleep Profiler LE Device Kit (Arm&Chin EMG)
• 00850015266676: Sleep Profiler LE Device Kit Dutch
• 00850015266829: Sleep Profiler LE Device Kit Polish
• 00850015266812: Sleep Profiler LE Device Kit (Arm&Chin EMG) Polish
• 00850015266706: Sleep Profiler RTA Software
• 00850015266959: Sleep Profiler LE Device Kit French
• 00850015266966: Sleep Profiler LE Device Kit Swiss
• 00850063034081: Sleep Profiler LE Device Kit Turkish
• 00850063034074: Sleep Profiler Device Kit Turkish (No sensors)
• 00850063034128: Sleep Profiler PSG2 LE Device