Breas Vivo 30 System 202000

GUDID 07321822020162

Continuous ventilator

Breas Medical AB

Portable electric ventilator

• Primary Device ID: 07321822020162
• NIH Device Record Key: 8e510617-52d5-4c41-aad7-1eee40c24e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breas Vivo 30 System
• Version Model Number: US
• Catalog Number: 202000
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321822020001 [Primary]
GS1	07321822020162 [Package]; Contains: 07321822020001; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060546

FDA Product Code

• MNS: Ventilator, Continuous, Non-Life-Supporting

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by Breas Medical AB

• 05060405720083 - Clearo: 2025-11-24 Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy.
• 07321820081691 - Clearo: 2025-11-24 Bacterial Filter
• 07321820082834 - Clearo: 2025-11-24 Internal Battery
• 07321820090655 - Clearo: 2025-11-24 Fine Air Inlet Filter, white
• 07321820090662 - Clearo: 2025-11-24 Coarse Air Inlet Filter, grey
• 07321820090679 - Clearo: 2025-11-24 Carry Bag Clearo
• 07321820106226 - Clearo Patient Circuit Americas: 2025-11-24 Clearo Patient Circuit Americas
• 07321820104727 - GCX- Vivo 45 Series Trolley: 2025-08-29 GCX Trolley for Vivo 45 Series