Identity
- Trade Name
- LNCS FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- LNCS Inf-3 Adhesive Sensor Reprocessed, 20/Box, Masimo FDA UDI
- Model / Reference
- 2691 FDA UDI
- Description
- LNCS Inf-3 Adhesive Sensor Reprocessed, 20/Box, Masimo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843997003398 FDA UDI
- 510(k) Number
- K101896 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
No
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
Lncs by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA UDI 78a2bccb-ea83-4ad5-9ef8-1f7e4c2a0d8d 36 fields · synced Jun 6, 2026