Identity
- Trade Name
- oximeter - RO2 FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382098017062 FDA UDI
- 510(k) Number
- K191430 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Pulse oximeter probe, reusable
oximeter - RO2 by Raya Pharmaceuticals Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Raya Pharmaceuticals Llc
Sources (1)
- FDA UDI 6797ef4f-8ec9-4b77-8802-2a2fc381db50 34 fields · synced May 29, 2026