Vivo 65 224516

GUDID 07321822245169

Continuos, Ventilator, Home Use

Breas Medical AB

Portable electric ventilator

• Primary Device ID: 07321822245169
• NIH Device Record Key: dd1af633-e9b2-459f-9562-d3e6cad4c0e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 65
• Version Model Number: US
• Catalog Number: 224516
• 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: +4631868860
• Email: techsupport@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321822240003 [Primary]
GS1	07321822245169 [Package]; Contains: 07321822240003; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160481

FDA Product Code

• NOU: Continuous, Ventilator, Home Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-24

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