SmartHeart 01-542

GUDID 00845717009034

SmartHeart Automatic Wrist Digital BP Monitor

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00845717009034
• NIH Device Record Key: 68d64207-28e8-4c03-965e-0ec7ed4d54c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartHeart
• Version Model Number: 01-542
• Catalog Number: 01-542
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717009034 [Primary]

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: 2018-06-21

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• 10845717008843: SmartHeart Ultra Premium Automatic Arm Digital BP Monitor
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