Breas Vivo 40 System 201000

GUDID 07321822010163

Continuous ventilator

Breas Medical AB

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator
Primary Device ID07321822010163
NIH Device Record Key6cde956e-9aeb-44a8-951a-78305e427ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreas Vivo 40 System
Version Model NumberUS
Catalog Number201000
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 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

Phone+4631868860
Emailtechsupport@breas.com
Phone+4631868860
Emailtechsupport@breas.com
Phone+4631868860
Emailtechsupport@breas.com
Phone+4631868860
Emailtechsupport@breas.com
Phone+4631868860
Emailtechsupport@breas.com
Phone+4631868860
Emailtechsupport@breas.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107321822010002 [Primary]
GS107321822010163 [Package]
Contains: 07321822010002
Package: Box [1 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by Breas Medical AB

07321820021857 - Vivo 50, Vivo 65, Vivo 45 LS2022-06-27 Memory Card Reader
07321820035229 - Vivo 45 LS2022-06-27 Power Cord US
07321820044269 - Vivo Series2022-06-27 Swivel Leakage Port
07321820045594 - Vivo 50, VIvo 652022-06-27 Click-On Battery
07321820048861 - Vivo 50, Vivo 652022-06-27 USB Cable A-B
07321820048915 - Vivo 502022-06-27 Nurse Call Cable NO
07321820048922 - Vivo 502022-06-27 Nurse Call Cable NC
07321820048939 - Vivo 502022-06-27 Nurse Call Cable NO, 10 KOhm

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