Identity
- Trade Name
- Nellcor FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- SpO2 Sensor, Multi-site Reusable;Sensor; (10) Adult-Neonatal Foam Sensor Wraps; (10) Pediatric-Infant Foam Sensor Wraps; (10) Adult/Neonatal Adhesive Sensor Wraps; (10) Pediatric/Infant Adhesive Sensor Wraps FDA UDI
- Model / Reference
- D-YS FDA UDI
- Description
- SpO2 Sensor, Multi-site Reusable;Sensor; (10) Adult-Neonatal Foam Sensor Wraps; (10) Pediatric-Infant Foam Sensor Wraps; (10) Adult/Neonatal Adhesive Sensor Wraps; (10) Pediatric/Infant Adhesive Sensor Wraps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884522042540 FDA UDI
- 510(k) Number
- K012891 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, reusable
Nellcor by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K012891 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
- Covidien LP
Sources (1)
- FDA UDI a153a4c5-6dbb-41da-b9f8-38fe51922db9 37 fields · synced May 30, 2026