SmartHeart 01-509

GUDID 10845717008843

SmartHeart Ultra Premium Automatic Arm Digital BP Monitor

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10845717008843
• NIH Device Record Key: 33c3f2d8-bf56-42f2-838e-5ca6e4991501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartHeart
• Version Model Number: 01-509
• Catalog Number: 01-509
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717008846 [Primary]
GS1	10845717008843 [Package]; Contains: 30845717008847; Package: Master Carton [12 Units]; In Commercial Distribution
GS1	30845717008847 [Package]; Contains: 00845717008846; Package: Intermediate [2 Units]; In Commercial Distribution

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

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• 10845717008843: SmartHeart Ultra Premium Automatic Arm Digital BP Monitor
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