| Primary Device ID | 07321820070060 |
| NIH Device Record Key | 0eaea782-e663-47cc-886d-7060d7452320 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivo 1/2, Vivo 3 |
| Version Model Number | 007006 |
| Catalog Number | 007006 |
| Company DUNS | 357007657 |
| Company Name | Breas Medical AB |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07321820070060 [Primary] |
| MNS | Ventilator, Continuous, Non-Life-Supporting |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 07321820070794 | SpO2 Adapter cable |
| 07321820070008 | Accessory Box |
| 07321820069903 | Heated Wire Patient Circuit |
| 07321820069774 | Attachable Humidifier |
| 07321820084272 | Circuit: Single limb 15 mm. Single patient multiple use (30-pack) |
| 07321820084265 | Circuit: Single limb 22 mm. Single patient multiple use (30-pack) |
| 07321820073801 | Lightweight Mobility Bag |
| 07321820072033 | Air Inlet Filter, grey (5pcs) |
| 07321820072026 | Air Inlet Filter, white (5pcs) |
| 07321820070145 | Protective Cover |
| 07321820070060 | Y Cable |
| 07321820067121 | Circuit: Single limb 15 mm. Single patient multiple use |
| 07321820044658 | Circuit: Single limb, 22 mm. Single, patient multiple use |