Identity
- Trade Name
- Nellcor FDA UDI
- Generic Name
- Electrical mains power extension cable FDA UDI
- Device Name
- Sensor Extension Cable FDA UDI
- Model / Reference
- DEC8 FDA UDI
- Description
- Sensor Extension Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884522042987 FDA UDI
- 510(k) Number
- K012891 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Electrical mains power extension cable 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
Dimensions & Sizes
- Size
- Length — 8 Feet FDA UDI
Category: Electrical mains power extension cable
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 30ffad5d-205a-4312-9476-606b5e334e56 37 fields · synced Jun 1, 2026