Vivo 50, Vivo 65 005066

GUDID 07321820050666

Polishing Cloth

Breas Medical AB

Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable Dry medical towel/wipe, reusable

• Primary Device ID: 07321820050666
• NIH Device Record Key: 1966846f-bc72-45ca-8093-44f1570f514a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 50, Vivo 65
• Version Model Number: 005066
• Catalog Number: 005066
• 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: 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
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321820050666 [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