Vivo 45 LS
Basic Information
- Brand Name
- Vivo 45 LS
- Primary DI
- 07321822300004
- Version / Model
- US
- Catalog Number
- 230000
- Company Name
- Breas Medical AB
- Labeler DUNS
- 357007657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 2
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 5b117907-d4f5-4b07-a558-550ba8ca0ba5
Device Description
The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers. Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support. The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery. The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47083 | Portable electric ventilator | A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07321822300004 | GS1 | ||||
| Package | 07321822300165 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 07321822302169 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 855-436-8724
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193586 | 000 |