Polysmith Version 9.0

GUDID 00817111020755

NEUROTRONICS, INC.

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• Primary Device ID: 00817111020755
• NIH Device Record Key: 27fa68a1-3495-446a-8c1a-ce71c37565e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysmith Version 9.0
• Version Model Number: 9.0
• Company DUNS: 036405363
• Company Name: NEUROTRONICS, 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: 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	00817111020755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062943

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: 5
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-22

Devices Manufactured by NEUROTRONICS, INC.

• 00817111021172 - Polysmith Version 12.0: 2020-04-09
• 00817111020748 - Polysmith Version 10.0: 2019-12-11
• 00817111020755 - Polysmith Version 9.0: 2019-12-11
• 00817111020755 - Polysmith Version 9.0: 2019-12-11
• 00817111020779 - Polysmith Version 11.0: 2019-12-11
• 00817111020786 - Live View Panel Version 1.3: 2019-12-11 Live View Panel Version 1.3
• 00817111020816 - Live View Panel Version 1.4: 2019-12-11 Live View Panel Version 1.4
• 00817111021141 - Nomad PMU800 Portable Recorder (USB): 2019-05-09 Nomad PMU800 Portable Recorder (USB)
• 00817111021158 - Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m: 2019-05-09 Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m