Vivo 50, VIvo 65 004910

GUDID 07321820046683

Patient Air Inlet filter (white, disposable), 10 pcs

Breas Medical AB

Portable electric ventilator
Primary Device ID07321820046683
NIH Device Record Keyc5a3449f-48d7-4e5c-996b-4934cf2d1ae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 50, VIvo 65
Version Model Number004910
Catalog Number004910
Company DUNS357007657
Company NameBreas Medical AB
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107321820046683 [Unit of Use]
GS107321820049103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility 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, VIvo 65]

07321820063444Protective Cover (replaces 004938)
07321820051892Click-on battery charger- US
07321820051007Vivo 50/65 PC Software
07321820050666Polishing Cloth
07321820049394Carry bag
07321820046683Patient Air Inlet filter (white, disposable), 10 pcs
07321820046676Patient Air Inlet filter (grey, washable), 5 pcs
07321820048991External battery cable 24V DC
07321820048861USB Cable A-B
07321820045594Click-On Battery

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.