Vivo 45 LS, Vivo 65 006348

GUDID 07321820063482

Remote Alarm w. ODU 10m cable

Breas Medical AB

Nurse call system alarm

• Primary Device ID: 07321820063482
• NIH Device Record Key: f9de4359-8b55-40e6-8a27-8e42d2d63ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivo 45 LS, Vivo 65
• Version Model Number: 006348
• Catalog Number: 006348
• 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: 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 Dimensions

• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter
• Length: 10 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321820063482 [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 45 LS, Vivo 65]

• 07321820063697: Masimo SpO2 Cable
• 07321820063659: Nurse call NO ODU cable
• 07321820063642: Nurse call NC ODU cable
• 07321820063635: Nurse Call Cable NO, 10 KOhm
• 07321820063628: Nurse Call Cable NC, 10 KOhm
• 07321820063611: Remote alarm cable, 50 m
• 07321820063604: Remote alarm cable, 25 m
• 07321820063598: Remote alarm cable, 10 m
• 07321820063499: Remote Alarm w. ODU 25m cable
• 07321820063482: Remote Alarm w. ODU 10m cable