Vivio System App

GUDID 00850044849024

Ventric Health

Cardiac mapping system application software

• Primary Device ID: 00850044849024
• NIH Device Record Key: 03c802c0-0637-4a08-850d-113359053fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivio System App
• Version Model Number: VA 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850044849024 [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
• 00850044849024 - Vivio System App: 2023-11-30
• 00850044849048 - Vivio System Arm Cuff: 2023-11-30
• 00850044849055 - Vivio System: 2023-11-30