Vivo 45 LS 230000

GUDID 07321822300004

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.

Breas Medical AB

Portable electric ventilator

• Primary Device ID: 07321822300004
• NIH Device Record Key: 5b117907-d4f5-4b07-a558-550ba8ca0ba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 45 LS
• Version Model Number: US
• Catalog Number: 230000
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321822300004 [Primary]
GS1	07321822300165 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	07321822302169 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193586

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [Vivo 45 LS]

• 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