Clearo 232000

GUDID 05060405720083

Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy.

Breas Medical AB

Positive pressure airway secretion-clearing device

• Primary Device ID: 05060405720083
• NIH Device Record Key: 7fae58df-f38c-45fd-926e-78718e10598e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearo
• Version Model Number: 232000
• Catalog Number: 232000
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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	05060405720083 [Primary]

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

On-Brand Devices [Clearo]

• 07321820090679: Carry Bag Clearo
• 07321820090662: Coarse Air Inlet Filter, grey
• 07321820090655: Fine Air Inlet Filter, white
• 07321820082834: Internal Battery
• 07321820081691: Bacterial Filter
• 05060405720083: Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) t