SmartHeart

GUDID 00845717010344

SmartHeart Talking Blood Pressure Monitor

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00845717010344
• NIH Device Record Key: dd299733-1b86-46c8-84ae-5fe2d3a77107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartHeart
• Version Model Number: 01-5811T
• Company DUNS: 830437997
• Company Name: VERIDIAN HEALTHCARE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717010344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222869

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2025-06-06
• Device Publish Date: 2025-05-29

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• 00845717009034: SmartHeart Automatic Wrist Digital BP Monitor
• 00845717008891: SmartHeart Automatic Wrist Digital BP Unit
• 00845717008884: SmartHeart Premium Talking Automatic Wrist Digital BP Monitor
• 00845717008839: Premium Talking Automatic Digital BP Monitor
• 00845717006798: Digital Wrist BP Monitor
• 10845717115015: SmartHeart Economy Pulse Oximeter - Walmart special packing
• 10845717015469: SmartHeart Talking Wrist Digital Blood Pressure Monitor
• 10845717008843: SmartHeart Ultra Premium Automatic Arm Digital BP Monitor
• 10845717006818: SmartHeart Talking Pulse Oximeter
• 30845717009202: SmartHeart Auto Digital BP Monitor, Wide Range Cuff
• 00845717010344: SmartHeart Talking Blood Pressure Monitor