Vivio System App

Primary DI
00850044849024
Brand
Vivio System App
Company
Ventric Health
Model
VA 1.0
Published
2023-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
00850044849024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044849024008500448490248500448490240850044849024

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system application softwareAn individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(626) 344-9665info@ventrichealth.com

Regulatory Flags#

DUNS number
080180146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044849079Vivio SystemVS 1.12025-09-08
00850044849086Vivio System EKG Patch2500222025-09-08
00850044849093Vivio System Arm Cuff2500282025-09-08
00850044849017Vivio System EKG PatchVP 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
00850044849079Vivio SystemVentric HealthQUO2025-09-08
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
00850044849048Vivio System Arm CuffVentric HealthQUO2023-11-22
00850044849055Vivio SystemVentric HealthQUO2023-11-22
05060634690041EchoGoULTROMICS LIMITEDQUO2023-02-15