Vivio System

GUDID 00850044849079

Ventric Health

Noninvasive multiple cardiovascular measurement unit
Primary Device ID00850044849079
NIH Device Record Keyd932d010-5002-4049-be3c-b80a422bcd90
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivio System
Version Model NumberVS 1.1
Company DUNS080180146
Company NameVentric Health
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850044849079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QUOAdjunctive Heart Failure Status Indicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-16
Device Publish Date2025-09-08

On-Brand Devices [Vivio System]

00850044849055VS 1.0
00850044849079VS 1.1

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