Vivo 45 LS

Basic Information

• Brand Name: Vivo 45 LS
• Primary DI: 07321820066490
• Version / Model: 006649
• Catalog Number: 006649
• Company Name: Breas Medical AB
• Labeler DUNS: 357007657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-18
• Public Version: 1
• Public Version Date: 2022-06-27
• Public Version Status: New
• Public Device Record Key: 631d1cbe-e43c-4ca5-b891-317b7dd17f1a

Device Description

Remote Start/Stop

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2
NOU	Continuous, Ventilator, Home Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35465	Assistive remote control	An electronic device designed as a control panel/unit, which may include a receiver, intended to assist a person with a disability to control and operate other devices remotely in their local environment. It includes multiple buttons/switches to allow control of various functions and includes characteristics (button size, simplicity) to allow ease of use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07321820066490	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193586	000