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

07321820044658 - Vivo 1/2, Vivo 32025-05-28 Circuit: Single limb, 22 mm. Single, patient multiple use
07321820067121 - Vivo 1/2, Vivo 32025-05-28 Circuit: Single limb 15 mm. Single patient multiple use
07321820070060 - Vivo 1/2, Vivo 32025-05-28 Y Cable
07321820070145 - Vivo 1/2, Vivo 32025-05-28 Protective Cover
07321820072026 - Vivo 1/2, Vivo 32025-05-28 Air Inlet Filter, white (5pcs)
07321820072033 - Vivo 1/2, Vivo 32025-05-28 Air Inlet Filter, grey (5pcs)
07321820073801 - Vivo 1/2, Vivo 32025-05-28 Lightweight Mobility Bag
07321820084265 - Vivo 1/2, Vivo 32025-05-28 Circuit: Single limb 22 mm. Single patient multiple use (30-pack)

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