Vivio System Arm Cuff

Primary DI
00850044849048
Brand
Vivio System Arm Cuff
Company
Ventric Health
Model
VC 1.1
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
00850044849048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044849048008500448490488500448490480850044849048

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080180146
Device count
1
Serial number
true
Manufacturing date on label
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
00850044849024Vivio System AppVA 1.02023-11-22
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
00850044849024Vivio System AppVentric HealthQUO2023-11-22
00850044849055Vivio SystemVentric HealthQUO2023-11-22
05060634690041EchoGoULTROMICS LIMITEDQUO2023-02-15