Vivo 45 LS, Vivo 65 006348

GUDID 07321820063482

Remote Alarm w. ODU 10m cable

Breas Medical AB

Nurse call system alarm Nurse call system alarm Nurse call system alarm Nurse call system alarm Nurse call system alarm Nurse call system alarm Nurse call system alarm 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