| Primary Device ID | B485CNSENV1000 |
| NIH Device Record Key | 56eb7828-af02-4618-ab72-729330a1918b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CNS Envision |
| Version Model Number | 1.03.00 |
| Company DUNS | 874257488 |
| Company Name | NATUS NEUROLOGY INCORPORATED |
| 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 |
|---|---|
| HIBCC | B485CNSENV1000 [Primary] |
| ORT | Burst Suppression Detection Software For 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 | 2023-08-28 |
| Device Publish Date | 2023-08-18 |
| 00382830032759 - Natus | 2025-02-14 EDX US / Canada + Base Unit |
| 00382830032872 - Natus | 2025-02-14 Synergy EDX International |
| 00382830034357 - Natus | 2025-02-14 2015 Visual Stimulator with LCD Monitor |
| 00382830034395 - Natus | 2025-02-14 2015 Visual Stimulator Only |
| 00382830035002 - Natus | 2025-02-14 EMG Reader Software |
| 00382830035019 - Natus | 2025-02-14 Natus Elite - Synergy & Viking Combo Master Software |
| 00382830035026 - Natus | 2025-02-14 Natus Elite - Viking Master Software |
| 00382830035033 - Natus | 2025-02-14 Natus Elite - Synergy Master Software |