Etekcity Smart Blood Pressure Monitor

GUDID 00817915020173

ETEKCITY CORPORATION

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• Primary Device ID: 00817915020173
• NIH Device Record Key: 23fe112d-6854-4daa-a4ad-3e56a526b175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etekcity Smart Blood Pressure Monitor
• Version Model Number: TMB-1583-BS-RXW
• 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	00817915020173 [Primary]
GS1	10817915020170 [Package]; Package: Outer Carton [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120058

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: 2021-02-08
• Device Publish Date: 2021-01-31

On-Brand Devices [Etekcity Smart Blood Pressure Monitor]

• 00817915020159: TMB-1583-BS
• 00817915020173: TMB-1583-BS-RXW