ETEKCITY BLOOD PRESSURE MONITOR

GUDID 00817915020029

ETEKCITY CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00817915020029
• NIH Device Record Key: a052dd26-3740-48f8-aedd-a9ad4563c2a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETEKCITY BLOOD PRESSURE MONITOR
• Version Model Number: EBP-UA5
• Company DUNS: 079578783
• Company Name: ETEKCITY 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: false
• Serial Number: false
• 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	00817915020029 [Primary]
GS1	10817915020026 [Package]; Package: Master Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180435

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-14

On-Brand Devices [ETEKCITY BLOOD PRESSURE MONITOR ]

• 00817915020029: EBP-UA5
• 10817915029159: EBP-M071S-WUS