| Primary Device ID | 03665023000627 |
| NIH Device Record Key | bd39ea2e-bf72-432a-b48e-e60e2247ffe2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NL-2-DEM |
| Version Model Number | NL-2-DEM |
| Catalog Number | NL-2-DEM |
| Company DUNS | 260233256 |
| Company Name | IDMED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 03665023000627 [Primary] |
| HLG | Pupillometer, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-21 |
| Device Publish Date | 2022-06-10 |
| 03665023000030 - TOF-MU | 2023-12-18 Main unit ToFscan |
| 03665023000122 - TOF-CHAR_US | 2023-12-18 AC Power / Charger (US electrical sockets) |
| 03665023000153 - TOF-STICKER1 | 2023-12-18 Double-sided stickers for eyebrow sensor (96 units) |
| 03665023000344 - TOF-MU | 2023-12-18 Main unit ToFscan |
| 03665023000047 - TOF-S2 | 2023-03-01 Hand sensor and electrodes connector |
| 03665023000078 - TOF-ES | 2023-03-01 Eyebrow sensor and electrodes connector |
| 03665023000368 - TOF-DEMO | 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp |
| 03665023000375 - TOF-DEMO_F | 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp |