SmartHeart 01-508

GUDID 00845717008891

SmartHeart Automatic Wrist Digital BP Unit

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00845717008891
• NIH Device Record Key: e3072a7e-a5a0-49f7-bae7-db9fe8615bdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartHeart
• Version Model Number: 01-508
• Catalog Number: 01-508
• 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	00845717008891 [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: 2018-03-29

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