MasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- LNCS DB-I SPO2 Adult Soft Reusable Sensor, 3 ft EUDAMEDMasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- LNCS SET Reusable Sensors EUDAMED
- Model / Reference
- 2653 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997003094 EUDAMEDFDA UDI
- Basic UDI-DI
- 084399700000Z1T1B04V004G6 EUDAMED
- Direct Marketing DI
- 00843997003094 EUDAMED
- 510(k) Number
- K113596 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable 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
No
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
No
Manufacturing Date
Yes
Category: Pulse oximeter probe, reusable
MasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor by Masimo Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Pulse oximeter probe, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- APK — Apk Technology · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K113596 also covers:
- MasimoSET DBI-dc3 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET DBI-dc8 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET M-LNCS Multisite-L Reusable Sensor — MASIMO CORPORATION
- MasimoSET® Red DBI-dc3 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET® Red DBI-dc8 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- RD SET — 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 cec88529-304d-4e1b-8ba8-a8b7268416a3 34 fields · synced Jul 10, 2026
- EUDAMED a054c3b9-a09a-47f4-8a6d-2b2ab61115fb 61 fields · synced Jul 10, 2026