| Primary Device ID | 04250413401932 |
| NIH Device Record Key | 2376de97-192e-475b-b428-21f213e88e0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOMNOscreen plus PSG+ AASM Set |
| Version Model Number | SSP201AU |
| Catalog Number | SSP201AU |
| Company DUNS | 314112173 |
| Company Name | SOMNOmedics GmbH |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250413401932 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-05 |
| Device Publish Date | 2016-09-23 |
| 04250413402748 - SOMNOwatch plus ACTI | 2023-12-15 |
| 04250413402755 - SOMNOwatch plus ACTI | 2023-12-15 |
| 04250413410781 - SOMNO HD / ECO accessory | 2023-12-08 |
| 04250413410828 - SOMNOscreen ECO EEG 32 | 2023-12-08 |
| 04250413410835 - SOMNOtouch RESP accessory | 2023-12-08 |
| 04250413410842 - SOMNOtouch RESP accessory | 2023-12-08 |
| 04250413410859 - SOMNOtouch RESP accessory | 2023-12-08 |
| 04250413400522 - SOMNOscreen Plus accessory | 2023-09-04 |