Polysmith Version 12.2

GUDID 00817111021257

Neurotronics, LLC

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• Primary Device ID: 00817111021257
• NIH Device Record Key: 73a71a61-5435-4741-8844-229c1a71de0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysmith Version 12.2
• Version Model Number: 12.2
• Company DUNS: 036405363
• Company Name: Neurotronics, LLC
• 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	00817111021257 [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: 2
• Public Version Date: 2023-04-14
• Device Publish Date: 2022-12-28

Devices Manufactured by Neurotronics, LLC

• 00817111020540 - Echo Polysomnography Playback Unit: 2023-06-15
• 00817111021189 - NomadAir PMU810 Portable Recorder: 2023-04-14
• 00817111021196 - NomadAir PMU810 RIP Belt, Small: 2023-04-14
• 00817111021202 - NomadAir PMU810 RIP Belt, Medium: 2023-04-14
• 00817111021219 - NomadAir PMU810 RIP Belt, Large: 2023-04-14
• 00817111021257 - Polysmith Version 12.2: 2023-04-14
• 00817111021257 - Polysmith Version 12.2: 2023-04-14