SmartHeart 01-546

GUDID 10845717015469

SmartHeart Talking Wrist Digital Blood Pressure Monitor

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10845717015469
• NIH Device Record Key: 57ad515c-bf8e-42de-88d0-f192f6eaf841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartHeart
• Version Model Number: 01-546
• Catalog Number: 01-546
• 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: false

Customer Support Contacts

• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com
• Phone: 866-326-1313
• Email: info@veridianhealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717015462 [Primary]
GS1	10845717015469 [Package]; Contains: 30845717015463; Package: Master Carton [12 Units]; In Commercial Distribution
GS1	30845717015463 [Package]; Contains: 00845717015462; Package: Intermediate [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092045

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-02

On-Brand Devices [SmartHeart]

• 00845717015561: SmartHeart Automatic Wrist Digital BP Uni
• 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