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

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Primary Device ID07321822300004
NIH Device Record Key5b117907-d4f5-4b07-a558-550ba8ca0ba5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 45 LS
Version Model NumberUS
Catalog Number230000
Company DUNS357007657
Company NameBreas Medical AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107321822300004 [Primary]
GS107321822300165 [Package]
Package: Box [1 Units]
In Commercial Distribution
GS107321822302169 [Package]
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-26
Device Publish Date2021-04-16

On-Brand Devices [Vivo 45 LS]

07321822300004The Vivo 45 LS Ventilator is a portable, microprocessor-controlled turbine based pressure suppor
073218200843642 m USB Cable- Micro for Vivo 45 LS
07321820083923PtcCO2 cable Radiometer TCM5
07321820077335Battery Charger 4 Bank
07321820077328Battery Charger 2 Bank
07321820076543Pilot Line Connector
07321820075553Lightweight Bag
07321820065561Filter, cooling air, Qty 5
07321820064564Filter, air inlet filter coarse, Qty 5
07321820064571Filter, air inlet filter fine, Qty 5
07321820070671PC Software Vivo 45 LS
07321820070640Air Bypass, Vivo 45 LS
07321820067114Cable, Y-adapter, Mains AC and External DC to Ventilator
07321820067107Cable, external DC to Ventilator Adapter
07321820067091External battery cable 24 V DC
07321820066490Remote Start/Stop
07321820063963Power supply
07321820062652Click-In Battery
07321820061808PtcCO2 cable Radiometer
07321820061792PtcCO2 cable Sentec
07321820061723FiO2 Sensor
07321820060672Protective Cover
07321820060146Carry bag
07321820035229Power Cord US
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