Identity
- Trade Name
- R-RUI FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Model / Reference
- RCT018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944290650580 FDA UDI
- 510(k) Number
- K222370 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, reusable
R-Rui by Beijing Rongrui-Century Scie. & Tech. Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222370 also covers:
- R-RUI — Beijing Rongrui-Century Scie. & Tech. Co., Ltd.
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- SPO2 AD CB, DATEX-OHMEDA 10M, DB9F, 2M — CURBELL MEDICAL PRODUCTS, INC.
- SPO2 AD CB, GE-MARQ 11M, DB9F OXMX, 2M — CURBELL MEDICAL PRODUCTS, INC.
- SPO2 AD CB, GE-MARQ 11M, DB9F OXMX, 3M — CURBELL MEDICAL PRODUCTS, INC.
- SPO2 AD CB, GE-MARQ 11M, DB9F, 2M — CURBELL MEDICAL PRODUCTS, INC.
- SPO2 AD CB, GE-MARQ 11M, DB9F, 3M — CURBELL MEDICAL PRODUCTS, INC.
- SPO2 AD CB, LEMO 5M, DB9F, 2M — CURBELL MEDICAL PRODUCTS, INC.
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
- Beijing Rongrui-Century Scie. & Tech. Co., Ltd.
Sources (1)
- FDA UDI e136dc99-0f54-462a-ac68-82287824787e 33 fields · synced May 30, 2026