Vivio System

Primary DI
00850044849079
Brand
Vivio System
Company
Ventric Health
Model
VS 1.1
Published
2025-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QUOAdjunctive Heart Failure Status Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUOAdjunctive Heart Failure Status IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223905000Vivio® LVEDP SystemAvicena, LLC2023-10-06QUO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044849079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044849079008500448490798500448490790850044849079

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive multiple cardiovascular measurement unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080180146
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044849086Vivio System EKG Patch2500222025-09-08
00850044849093Vivio System Arm Cuff2500282025-09-08
00850044849017Vivio System EKG PatchVP 1.02023-11-22
00850044849024Vivio System AppVA 1.02023-11-22
00850044849048Vivio System Arm CuffVC 1.12023-11-22
00850044849055Vivio SystemVS 1.02023-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044849086Vivio System EKG PatchVentric HealthQUO2025-09-08
00850044849093Vivio System Arm CuffVentric HealthQUO2025-09-08
05060634690058EchoGoULTROMICS LIMITEDQUO2024-12-17
00850044849017Vivio System EKG PatchVentric HealthQUO2023-11-22
00850044849024Vivio System AppVentric HealthQUO2023-11-22
00850044849048Vivio System Arm CuffVentric HealthQUO2023-11-22
00850044849055Vivio SystemVentric HealthQUO2023-11-22
05060634690041EchoGoULTROMICS LIMITEDQUO2023-02-15