Vivio System

Basic Information

• Brand Name: Vivio System
• Primary DI: 00850044849055
• Version / Model: VS 1.0
• Company Name: Ventric Health
• Labeler DUNS: 080180146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-22
• Public Version: 1
• Public Version Date: 2023-11-30
• Public Version Status: New
• Public Device Record Key: 596ff1bc-f2bb-41fb-8054-5ad2935465b3

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
QUO	Adjunctive Heart Failure Status Indicator	Cardiovascular	870.2200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60387	Noninvasive multiple cardiovascular measurement unit	An automated, mains electricity (AC-powered), portable electronic device designed to measure multiple cardiovascular parameters [including electrocardiogram (ECG), phonocardiogram (PCG), carotid pulse tracing, femoral pulse tracing and four limb pulse tracing/blood pressure] to assist in the diagnosis of cardiac and/or peripheral vascular disease. It typically consists of a control/analysis/display unit with cuffs, electrodes, audio and pressure sensors placed in strategic positions around the body. The device is typically operated by a healthcare professional.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850044849055	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223905	000