| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00817111021257 [Primary] |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-04-14 |
| Device Publish Date | 2022-12-28 |
| 00817111021332 - Polysmith | 2025-10-01 |
| 00817111021264 - Live View Panel Pro Version 2.0 | 2024-05-17 Live View Panel Pro Version 2.0 |
| 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 |