Clearo Patient Circuit Americas 010466

GUDID 07321820106226

Clearo Patient Circuit Americas

Breas Medical AB

Positive pressure airway secretion-clearing device

• Primary Device ID: 07321820106226
• NIH Device Record Key: f10aeefc-b3c3-40e7-bac9-90944e2b2620
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearo Patient Circuit Americas
• Version Model Number: 010466
• Catalog Number: 010466
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• Device Count: 10
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321820104666 [Primary]
GS1	07321820106226 [Unit of Use]

FDA Product Code

• NHJ: Device, Positive Pressure Breathing, Intermittent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-11-24
• Device Publish Date: 2025-11-03

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: 2025-11-24Clearo Patient Circuit Americas
• 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