Identity
- Trade Name
- LNCS Neo Newborn Adhesive Sensor, 20/Box, Masimo EUDAMEDLNCS FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- LNCS SET Disposable Sensors EUDAMEDLNCS Neo Newborn Adhesive Sensor, 20/Box, Masimo FDA UDI
- Model / Reference
- 5265 EUDAMEDFDA UDI
- Description
- LNCS Neo Newborn Adhesive Sensor, 20/Box, Masimo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997017357 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V100G3 EUDAMED
- Unit of Use DI
- 00843997017350 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Lncs by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 62106b30-3905-49da-9d0a-26d7f1eb4b18 35 fields · synced Jul 9, 2026
- EUDAMED aa80cfeb-371f-4cc7-81f7-4a0fa600e8c4 61 fields · synced Jul 9, 2026