M-LNCS INF-3, infant SpO2 adhesive sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LNCS Inf EUDAMEDLNCS Inf-3 EUDAMEDM-LNCS INF-3, infant SpO2 adhesive sensor FDA UDIMasimoSET® LNCS® Inf Infant Pulse Oximeter Adhesive Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- LNCS SET Disposable Sensors EUDAMEDMasimoSET LNCS Inf Infant Pulse Oximeter Adhesive Sensor FDA UDI
- Model / Reference
- 2319 EUDAMEDFDA UDI2328 EUDAMEDFDA UDI2912-5 FDA UDI
- Description
- MasimoSET LNCS Inf Infant Pulse Oximeter Adhesive Sensor FDA UDI
Identifiers
- Catalog Number
- 2319 FDA UDI2328 FDA UDI
- Primary DI / UDI-DI
- 10843997000885 EUDAMEDFDA UDI10843997000915 EUDAMEDFDA UDI10843997004753 FDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V100G3 EUDAMED
- Unit of Use DI
- 00843997000918 EUDAMED00843997000888 EUDAMED
- 510(k) Number
- K101896 FDA UDI
- 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulse oximeter probe, single-use
M-LNCS INF-3, infant SpO2 adhesive sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
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- Nonin — Nonin Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 (5)
- FDA UDI e7f49816-015e-440b-92da-fe87a0b6ef79 33 fields · synced Jul 29, 2026
- FDA UDI bf59efc3-519e-4117-bac1-464e47c8cb69 37 fields · synced May 30, 2026
- FDA UDI 462557d8-71b5-46c8-bfe6-6bbee559e839 37 fields · synced May 30, 2026
- EUDAMED 3aad242d-4133-42e0-826d-c36d4f98d124 61 fields · synced Jul 11, 2026
- EUDAMED 3c350590-7470-4c4f-9e2a-0bfeda8e6619 61 fields · synced Jul 29, 2026