YUWELL®Finger Pulse Oximeter

GUDID 06933257921948

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight > 30kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion.

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Pulse oximeter

• Primary Device ID: 06933257921948
• NIH Device Record Key: 1d820dd9-5b13-4fd4-9519-d6e6b87889ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL®Finger Pulse Oximeter
• Version Model Number: YX102
• Company DUNS: 528704000
• Company Name: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933257921948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212385

FDA Product Code

• DQA: Oximeter

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: 2025-06-24
• Device Publish Date: 2025-06-16

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