YUWELL Electronic Blood Pressure Monitor

GUDID 06933257921610

YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06933257921610
• NIH Device Record Key: 4ad44fa7-8287-4a69-8fa6-17929e927ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Electronic Blood Pressure Monitor
• Version Model Number: YE8800CR
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933257921610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221372

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: 2024-05-31
• Device Publish Date: 2024-05-23

Devices Manufactured by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

• 06933257922747 - YUWELL Infrared Thermometer: 2024-07-08 The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperatu
• 06933257921610 - YUWELL Electronic Blood Pressure Monitor: 2024-05-31YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
• 06933257921610 - YUWELL Electronic Blood Pressure Monitor: 2024-05-31 YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended