Identity
- Trade Name
- YUWELL® Finger Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- YX306 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06933257921993 FDA UDI
- 510(k) Number
- K212385 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter
YUWELL® Finger Pulse Oximeter by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212385 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Sources (1)
- FDA UDI d3543114-09c9-46b7-8938-fb8c0188b2d7 34 fields · synced May 30, 2026