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M-LNCS Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- M-LNCS Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Model / Reference
- 2913-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997004760 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter probe, single-use
M-LNCS Neo SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (2)
- FDA UDI 1252b951-5257-4a4a-9456-eaa09fa70658 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026