Identity
- Trade Name
- Nellcor FDA UDI
- Generic Name
- Carbon dioxide monitor FDA UDI
- Device Name
- N-600x Pulse Oximeter Alarm Management System FDA UDI
- Model / Reference
- N600x-A FDA UDI
- Description
- N-600x Pulse Oximeter Alarm Management System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521211148 FDA UDI
- 510(k) Number
- K123581 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Carbon dioxide monitor 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carbon dioxide monitor
Nellcor by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Carbon dioxide monitor.
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- cap-ONE — Nihon Kohden Corp. · Class I
- Nonin — Nonin Medical, Inc. · Class II
Cleared under the same submission
K123581 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 97394be5-4293-4ed8-b544-4b7ded726364 36 fields · synced May 31, 2026