Vivo 45 LS 003522

GUDID 07321820035229

Power Cord US

Breas Medical AB

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable
Primary Device ID07321820035229
NIH Device Record Key3f9577bb-b4e4-4c9d-bf88-d24ed2370ef0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 45 LS
Version Model Number003522
Catalog Number003522
Company DUNS357007657
Company NameBreas Medical AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107321820035229 [Primary]

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 Date2022-06-27
Device Publish Date2022-06-18

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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