Sleep Profiler PSG2

GUDID 00851113007307

Sleep Profiler PM3 Upgrade kit

ADVANCED BRAIN MONITORING, INC.

Home-use sleep apnoea recording system

• Primary Device ID: 00851113007307
• NIH Device Record Key: 75afa8a7-7801-434f-a447-9ad0ce2b4df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleep Profiler PSG2
• Version Model Number: SP29-1010
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851113007307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152040

FDA Product Code

• OLV: Standard 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: 2016-09-24

On-Brand Devices [Sleep Profiler PSG2]

• 00851113007338: Wrist Oximeter
• 00851113007321: Sleep Profiler PSG2 Upgrade Kit - Piezo
• 00851113007314: Sleep Profiler PSG2 upgrade Kit - ezRIP
• 00851113007307: Sleep Profiler PM3 Upgrade kit
• 00851113007246: 50-Night Study Kit - Sleep Profiler PSG2/PM3
• 00851113007192: Airflow Adapter Kit
• 00851113007178: Effort Cable Standard Kit
• 00850015266201: Effort Cable Single Channel Kit
• 00850015266546: Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German
• 00850015266850: Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German with cables
• 00850015266669: Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
• 00850015266256: Sleep Profiler PSG2 LE Device Kit (No Belts / PM3) with cables
• 00850015266867: Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF)
• 00850015266874: Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
• 00850015266942: Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
• 00850015266997: Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
• 00850015266980: Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
• 00850015266973: Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss