Easy@Home Blood Pressure Monitor

GUDID 10810038630028

EASY HEALTHCARE CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10810038630028
• NIH Device Record Key: 055784fb-2f8d-4f77-b369-94ef2ca7c860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Blood Pressure Monitor
• Version Model Number: EBP-020
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• 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: true
• 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	00810038630021 [Primary]
GS1	10810038630028 [Package]; Contains: 00810038630021; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182495

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: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [Easy@Home Blood Pressure Monitor ]

• 00850253007185: EBP-095
• 00850003180090: EBP-095
• 00810038630175: EBP-095
• 10810038630028: EBP-020