MasimoSET® LNCS® Pdtx Pediatric Pulse Oximeter Adhesive Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LNCS Pdtx-3 EUDAMEDMasimoSET® LNCS® Pdtx Pediatric Pulse Oximeter Adhesive Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- LNCS SET Disposable Sensors EUDAMEDMasimoSET LNCS Pdtx Pediatric Pulse Oximeter Adhesive Sensor FDA UDI
- Model / Reference
- 2318 EUDAMEDFDA UDI
- Description
- MasimoSET LNCS Pdtx Pediatric Pulse Oximeter Adhesive Sensor FDA UDI
Identifiers
- Catalog Number
- 2318 FDA UDI
- Primary DI / UDI-DI
- 10843997000878 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V100G3 EUDAMED
- Unit of Use DI
- 00843997000871 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
MasimoSET® LNCS® Pdtx Pediatric Pulse Oximeter Adhesive Sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Pulse oximeter probe, single-use.
- APK — Apk Technology · Class II
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- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- BluSat — OSI OPTOELECTRONICS, INC. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Nonin — Nonin Medical, Inc. · Class II
Cleared under the same submission
K101896 also covers:
- 14 pin to 20 pin Adapter Cable — MASIMO CORPORATION
- LNCS — MASIMO CORPORATION
- LNCS — MASIMO CORPORATION
- LNCS Inf-L infant SpO2 adhesive sensor — MASIMO CORPORATION
- LNCS NeoL SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION
- LNCS® Adult Sample Pack — MASIMO CORPORATION
- LNCS® Inf-L SpO2 Infant Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION
- LNCS® Pdtx SpO2 Pediatric Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION
- LNCS® Sensor Sample Pack — MASIMO CORPORATION
- LNCS® Sensor Training Kit — MASIMO CORPORATION
- M-LNC-10-NK M-LNCs™ to NK Patient Cable — MASIMO CORPORATION
- M-LNCS™ Adult Sample Pack — MASIMO CORPORATION
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 (2)
- FDA UDI d84d75dd-b954-4806-9e69-c77a59eeb668 37 fields · synced Jul 13, 2026
- EUDAMED cff14272-70a8-431a-90c4-3c712294266b 61 fields · synced Jul 13, 2026