Vivo 50, VIvo 65 004910

GUDID 07321820046683

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

Breas Medical AB

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator

• Primary Device ID: 07321820046683
• NIH Device Record Key: c5a3449f-48d7-4e5c-996b-4934cf2d1ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 50, VIvo 65
• Version Model Number: 004910
• Catalog Number: 004910
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• Device Count: 10
• 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: true
• Lot Batch: false
• Serial Number: false
• 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
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321820046683 [Unit of Use]
GS1	07321820049103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123144

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-18

On-Brand Devices [Vivo 50, VIvo 65]

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