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MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2601Ref 2317
Identity
- Trade Name
- LNCS Adtx-3 EUDAMEDMasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor FDA UDILNCS Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor FDA UDIMasimoSET® LNCS® Adtx Adult Pulse Oximeter Adhesive Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- LNCS SET Disposable Sensors EUDAMEDMasimoSET LNCS Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor FDA UDIMasimoSET LNCS Adtx Adult Pulse Oximeter Adhesive Sensor FDA UDI
- Model / Reference
- 2601 EUDAMEDFDA UDI2317 EUDAMEDFDA UDI2908-5 FDA UDI
- Description
- MasimoSET LNCS Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor FDA UDIMasimoSET LNCS Adtx Adult Pulse Oximeter Adhesive Sensor FDA UDI
Identifiers
- Catalog Number
- 2601 FDA UDI2317 FDA UDI
- Primary DI / UDI-DI
- 10843997002797 EUDAMEDFDA UDI10843997000861 EUDAMEDFDA UDI10843997004715 FDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V103G9 EUDAMED084399700000Z1T1B04V100G3 EUDAMED
- Unit of Use DI
- 00843997002790 EUDAMED00843997000864 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
EUDAMEDFDA UDIFDA 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
MasimoSET® LNCS® Adtx-3 SpO2 Adult 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
- Spo2 sensor — Orantech Inc. · Class IIb
- 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
- RUI — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIb
- Unimed — Unimed Medical Supplies, 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
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 (5)
- FDA UDI de3a28c1-3e2c-4371-814d-101f02d0595e 37 fields · synced Oct 6, 2026
- FDA UDI c5c6032e-b45e-41fb-ab30-f4ccc893660c 33 fields · synced May 30, 2026
- FDA UDI 1869fee8-d81f-4527-b6f0-d8f152aaaf4f 37 fields · synced May 30, 2026
- EUDAMED b3c9915a-01d7-4f50-bb81-fc9052a846b9 61 fields · synced Jul 15, 2026
- EUDAMED e0570abc-b785-4602-99df-794777bebc1f 61 fields · synced Sep 17, 2026