Vivio System

GUDID 00850044849055

Ventric Health

Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit Noninvasive multiple cardiovascular measurement unit

• Primary Device ID: 00850044849055
• NIH Device Record Key: 596ff1bc-f2bb-41fb-8054-5ad2935465b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivio System
• Version Model Number: VS 1.0
• Company DUNS: 080180146
• Company Name: Ventric Health
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com
• Phone: (626)344-9665
• Email: info@ventrichealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044849055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223905

FDA Product Code

• QUO: Adjunctive Heart Failure Status Indicator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

Devices Manufactured by Ventric Health

• 00850044849017 - Vivio System EKG Patch: 2023-11-30
• 00850044849024 - Vivio System App: 2023-11-30
• 00850044849048 - Vivio System Arm Cuff: 2023-11-30
• 00850044849055 - Vivio System: 2023-11-30
• 00850044849055 - Vivio System: 2023-11-30