| Primary Device ID | 07321820060672 |
| NIH Device Record Key | f3cf953f-204a-4bc3-8336-0f68270e7479 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivo 45 LS |
| Version Model Number | 006067 |
| Catalog Number | 006067 |
| Company DUNS | 357007657 |
| Company Name | Breas Medical AB |
| 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 |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07321820060672 [Primary] |
| CBK | Ventilator, Continuous, Facility Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-18 |
| 07321822300004 | The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based pressure suppor |
| 07321820084364 | 2 m USB Cable- Micro for Vivo 45 LS |
| 07321820083923 | PtcCO2 cable Radiometer TCM5 |
| 07321820077335 | Battery Charger 4 Bank |
| 07321820077328 | Battery Charger 2 Bank |
| 07321820076543 | Pilot Line Connector |
| 07321820075553 | Lightweight Bag |
| 07321820065561 | Filter, cooling air, Qty 5 |
| 07321820064564 | Filter, air inlet filter coarse, Qty 5 |
| 07321820064571 | Filter, air inlet filter fine, Qty 5 |
| 07321820070671 | PC Software Vivo 45 LS |
| 07321820070640 | Air Bypass, Vivo 45 LS |
| 07321820067114 | Cable, Y-adapter, Mains AC and External DC to Ventilator |
| 07321820067107 | Cable, external DC to Ventilator Adapter |
| 07321820067091 | External battery cable 24 V DC |
| 07321820066490 | Remote Start/Stop |
| 07321820063963 | Power supply |
| 07321820062652 | Click-In Battery |
| 07321820061808 | PtcCO2 cable Radiometer |
| 07321820061792 | PtcCO2 cable Sentec |
| 07321820061723 | FiO2 Sensor |
| 07321820060672 | Protective Cover |
| 07321820060146 | Carry bag |
| 07321820035229 | Power Cord US |