Blood Pressure Monitor

GUDID 06972797030116

This is an arm type blood pressure monitor. The monitor features blood pressure measurement, pulse rate measurement and the result storage.

Shenzhen Yuangu Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06972797030116
• NIH Device Record Key: 3529fde2-bb76-4fec-8e24-8b54019373be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Pressure Monitor
• Version Model Number: TMB-1583-S
• Company DUNS: 417870361
• Company Name: Shenzhen Yuangu Technology Co., Ltd.
• 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: 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	06972797030116 [Primary]
GS1	36972797030117 [Package]; Package: 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: 2019-11-27
• Device Publish Date: 2019-11-19