| Primary Device ID | 07321820061259 |
| NIH Device Record Key | 7c67c7bc-f9a0-46e7-af5e-a882d66388cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivo 65 |
| Version Model Number | 006435 |
| Catalog Number | 006435 |
| Company DUNS | 357007657 |
| Company Name | Breas Medical AB |
| Device Count | 5 |
| 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 | 07321820061259 [Unit of Use] |
| GS1 | 07321820064359 [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 |
| 07321822245169 | Continuos, Ventilator, Home Use |
| 07321820061259 | Air Cool Filter 5 pack |
| 07321820063420 | Remote Start/Stop |
| 07321820057917 | Dual Limb insert, Paediatric |
| 07321820057900 | Dual Limb Insert, disposable, Adult |
| 07321820055210 | Single Limb Insert |
| 07321820054329 | Power cord US |