Vivio System EKG Patch

GUDID 00850044849086

Ventric Health

Electrocardiograph, professional, single-channel

• Primary Device ID: 00850044849086
• NIH Device Record Key: 4d58b3c7-8502-4c11-85c3-346869726af0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivio System EKG Patch
• Version Model Number: 250022
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044849086 [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: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [Vivio System EKG Patch]

• 00850044849017: VP 1.0
• 00850044849086: 250022