Easy@Home Arm Blood Pressure Monitor EBP-08B

GUDID 10810038632565

EASY HEALTHCARE CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10810038632565
• NIH Device Record Key: aee55f59-bc6c-4a04-aca7-519e88631d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Arm Blood Pressure Monitor
• Version Model Number: EBP-08B
• Catalog Number: EBP-08B
• 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: true
• 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	00810038632568 [Primary]
GS1	10810038632565 [Package]; Contains: 00810038632568; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131395

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: 2022-05-16
• Device Publish Date: 2022-05-07

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