Vivo 50 004892

GUDID 07321820048922

Nurse Call Cable NC

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 ID07321820048922
NIH Device Record Key4e24aa84-7e02-4a88-9f50-0d23957b94c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 50
Version Model Number004892
Catalog Number004892
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 Batchtrue
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
GS107321820048922 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-27
Device Publish Date2022-06-18

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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