Vivo 50 215116

GUDID 07321822151163

Continuous, Ventilator, Home Use

Breas Medical AB

Portable electric ventilator

• Primary Device ID: 07321822151163
• NIH Device Record Key: 31ae50e3-8bcd-4df6-b9f1-bfdf6b7eb33c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 50
• Version Model Number: US
• Catalog Number: 215116
• 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: 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: 844-848-6872
• Email: support@breas.us
• Phone: 844-848-6872
• Email: support@breas.us
• Phone: 844-848-6872
• Email: support@breas.us
• Phone: 844-848-6872
• Email: support@breas.us
• Phone: 844-848-6872
• Email: support@breas.us
• Phone: 844-848-6872
• Email: support@breas.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321822151163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123144

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: 2015-10-06

On-Brand Devices [Vivo 50]

• 07321822151163: Continuous, Ventilator, Home Use
• 07321822150166: Continuous, Ventilator, Home Use
• 07321822150005: Continuous, Ventilator, Home Use
• 07321820072194: Power Cord US - 12 ft
• 07321820059287: PC Software
• 07321820054299: iOxy Vivo 50 Flex sensor
• 07321820054282: iOxy Vivo 50 Finger clip sensor
• 07321820052233: Remote Alarm incl cable 25m
• 07321820050949: Isolated USB cable kit
• 07321820050369: Remote Alarm incl cable 10m
• 07321820048984: Remote alarm cable 50m
• 07321820048977: Remote alarm cable 25m
• 07321820048960: Remote alarm cable 10m
• 07321820048946: Nurse call cable NC, 10K Ohm
• 07321820048939: Nurse Call Cable NO, 10 KOhm
• 07321820048922: Nurse Call Cable NC
• 07321820048915: Nurse Call Cable NO