| Primary Device ID | 00817111020335 |
| NIH Device Record Key | 6e82c8d0-7e38-4f1b-ad6a-bf1b50521cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sphinx HB710 Head Box |
| Version Model Number | HB710 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00817111020335 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 00817111021172 - Polysmith Version 12.0 | 2020-04-09 |
| 00817111020748 - Polysmith Version 10.0 | 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 |