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8000R Reusable Reflectance Pulse Oximetry Sensor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 114240-001Model PKG ASSY, 8000R WITH 3150I ADAPTER CABLE
Identity
- Trade Name
- 8000R Reusable Reflectance Pulse Oximetry Sensor EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- 8000R Reusable Reflectance Pulse Oximetry Sensor EUDAMEDFOREHEAD SENSOR FOR 3150I FDA UDI
- Model / Reference
- PKG ASSY, 8000R WITH 3150I ADAPTER CABLE EUDAMED114240-001 EUDAMED8000R FDA UDI
- Description
- FOREHEAD SENSOR FOR 3150I FDA UDI
Identifiers
- Catalog Number
- 114240-001 FDA UDI
- Primary DI / UDI-DI
- 00849686050929 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849686050929 EUDAMED
- 510(k) Number
- K050056 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, single-use
8000R Reusable Reflectance Pulse Oximetry Sensor by Nonin Medical, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
- APK — Apk Technology · Class II
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- MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- M-LNCS — MASIMO CORPORATION · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849686050929 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nonin Medical, Inc.
- EUDAMED SRN
- US-MF-000008228
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED fc5b6f3e-5b0b-45c8-bb36-581ae5862161 61 fields · synced Jun 19, 2026
- FDA UDI e8c21c80-6020-46e9-99ae-4c17cd18e851 35 fields · synced May 30, 2026