Vivo 50 005429

GUDID 07321820054299

iOxy Vivo 50 Flex sensor

Breas Medical AB

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 07321820054299
• NIH Device Record Key: 3d4b9fd4-efb1-4b91-a68e-3ed164f84998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 50
• Version Model Number: 005429
• Catalog Number: 005429
• 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: 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	07321820054299 [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: 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]

• 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