YUWELL Electronic Blood Pressure Monitor

GUDID 06933257914124

The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06933257914124
• NIH Device Record Key: 378b59df-7a45-4632-bfee-a326f7ed3411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Electronic Blood Pressure Monitor
• Version Model Number: YE620B
• Company DUNS: 528704000
• Company Name: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06933257914124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200939

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: 2025-06-17
• Device Publish Date: 2025-06-09

On-Brand Devices [YUWELL Electronic Blood Pressure Monitor]

• 06933257921610: YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pre
• 06933257914124: The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillat
• 06933257921634: YE8800AR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pre
• 06933257916593: The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillat