| Primary Device ID | 15694311111665 |
| NIH Device Record Key | 912ebfda-4de3-4b63-bce6-2527c6b38759 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Noxturnal US APP |
| Version Model Number | NOX-NOXTURNAL_US_APP |
| Company DUNS | 365741462 |
| Company Name | Nox Medical ehf. |
| 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 | false |
| Manufacturing Date | false |
| 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 | 15694311111665 [Primary] |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-26 |
| Device Publish Date | 2021-10-18 |
| 15694311111665 - Noxturnal US APP | 2021-10-26 |
| 15694311111665 - Noxturnal US APP | 2021-10-26 |
| 15694311111610 - Nox A1® EEG 5 Lead Gold Electrode Cable | 2021-09-15 |
| 15694311111627 - Nox A1® EEG Head Cable | 2021-09-15 |
| 15694311111566 - Nox A1s Recorder | 2021-07-19 |
| 15694311111580 - Nox A1s System | 2021-07-19 |
| 15694311111597 - Nox C1s Kit | 2021-07-19 |
| 15694311111467 - Nox T3s System | 2021-06-08 |
| 15694311110682 - Nox A1 Starter Sensor Kit, Adult | 2021-02-11 |