GCX- Vivo 45 Series Trolley 010472

GUDID 07321820104727

GCX Trolley for Vivo 45 Series

Breas Medical AB

Electromechanical device/system transport trolley
Primary Device ID07321820104727
NIH Device Record Keyd5a9c261-0cf5-4dec-bdf2-0e5c430611e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGCX- Vivo 45 Series Trolley
Version Model Number010472
Catalog Number010472
Company DUNS357007657
Company NameBreas Medical AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
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
GS107321820104727 [Primary]

FDA Product Code

FOXStand, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-29
Device Publish Date2025-08-21

Devices Manufactured by Breas Medical AB

07321820104727 - GCX- Vivo 45 Series Trolley2025-08-29GCX Trolley for Vivo 45 Series
07321820104727 - GCX- Vivo 45 Series Trolley2025-08-29 GCX Trolley for Vivo 45 Series
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.