Vivio System Arm Cuff

GUDID 00850044849093

Ventric Health

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00850044849093
• NIH Device Record Key: ad161e81-0c3d-4909-b0d9-5ceb348a34bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivio System Arm Cuff
• Version Model Number: 250028
• 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	00850044849093 [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 Arm Cuff]

• 00850044849048: VC 1.1
• 00850044849093: 250028