Vivo 50 215016

GUDID 07321822150166

Continuous, Ventilator, Home Use

Breas Medical AB

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator
Primary Device ID07321822150166
NIH Device Record Key88837b1e-9bbb-434b-97ed-5cb61c98ecfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 50
Version Model NumberUS
Catalog Number215016
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

Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us
Phone844-848-6872
Emailsupport@breas.us

Device Identifiers

Device Issuing AgencyDevice ID
GS107321822150166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NOUContinuous, Ventilator, Home 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 Date2015-10-07

On-Brand Devices [Vivo 50]

07321822151163Continuous, Ventilator, Home Use
07321822150166Continuous, Ventilator, Home Use
07321822150005Continuous, Ventilator, Home Use
07321820072194Power Cord US - 12 ft
07321820059287PC Software
07321820054299iOxy Vivo 50 Flex sensor
07321820054282iOxy Vivo 50 Finger clip sensor
07321820052233Remote Alarm incl cable 25m
07321820050949Isolated USB cable kit
07321820050369Remote Alarm incl cable 10m
07321820048984Remote alarm cable 50m
07321820048977Remote alarm cable 25m
07321820048960Remote alarm cable 10m
07321820048946Nurse call cable NC, 10K Ohm
07321820048939Nurse Call Cable NO, 10 KOhm
07321820048922Nurse Call Cable NC
07321820048915Nurse Call Cable NO

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