Vivo 3 229500

GUDID 07321822290008

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Breas Medical AB

Portable electric ventilator
Primary Device ID07321822290008
NIH Device Record Key800f7e4e-df88-43db-8037-cbf6629b1b5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 3
Version Model NumberVivo 3
Catalog Number229500
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
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
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
GS107321822290008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-27
Device Publish Date2025-05-19

Devices Manufactured by Breas Medical AB

05060405720083 - Clearo2025-11-24 Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy.
07321820081691 - Clearo2025-11-24 Bacterial Filter
07321820082834 - Clearo2025-11-24 Internal Battery
07321820090655 - Clearo2025-11-24 Fine Air Inlet Filter, white
07321820090662 - Clearo2025-11-24 Coarse Air Inlet Filter, grey
07321820090679 - Clearo2025-11-24 Carry Bag Clearo
07321820106226 - Clearo Patient Circuit Americas2025-11-24 Clearo Patient Circuit Americas
07321820104727 - GCX- Vivo 45 Series Trolley2025-08-29 GCX Trolley for Vivo 45 Series

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