Vivo 65 005521

GUDID 07321820055210

Single Limb Insert

Breas Medical AB

Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use Mechanical expiratory valve, single-use

• Primary Device ID: 07321820055210
• NIH Device Record Key: d36799d3-39e3-4129-8c12-a3eefc70f0a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 65
• Version Model Number: 005521
• Catalog Number: 005521
• 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: true
• 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
• Phone: 855-436-8724
• Email: supportUS@breas.com
• Phone: 855-436-8724
• Email: supportUS@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321820055210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160481

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 65]

• 07321822245169: Continuos, Ventilator, Home Use
• 07321820061259: Air Cool Filter 5 pack
• 07321820063420: Remote Start/Stop
• 07321820057917: Dual Limb insert, Paediatric
• 07321820057900: Dual Limb Insert, disposable, Adult
• 07321820055210: Single Limb Insert
• 07321820054329: Power cord US