PoSAS

GUDID 00851113007758

PoSAS Desktop Software

ADVANCED BRAIN MONITORING, INC.

Medical equipment clinical data interfacing software

• Primary Device ID: 00851113007758
• NIH Device Record Key: b46a20c8-73f7-403c-80bc-d39d05de63e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PoSAS
• Version Model Number: PS34-5401
• 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	00851113007758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172799

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2018-11-08
• Device Publish Date: 2018-03-19

Devices Manufactured by ADVANCED BRAIN MONITORING, INC.

• 00850063034128 - Sleep Profiler: 2025-02-05 Sleep Profiler PSG2 LE Device
• 00850063034142 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit (No Belts / PM3) with cables
• 00850063034159 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF)
• 00850063034197 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German with cables
• 00850063034203 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
• 00850063034210 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
• 00850063034227 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
• 00850063034234 - Sleep Profiler PSG2: 2025-02-05 Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German