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8000Q2 Reusable Ear Clip Pulse Oximetry Sensor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 114239-001Model PKG ASSY, 8000Q2 WITH 3150I ADAPTER CABLE
Identity
- Trade Name
- 8000Q2 Reusable Ear Clip Pulse Oximetry Sensor EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- 8000Q2 Reusable Ear Clip Pulse Oximetry Sensor EUDAMEDEAR CLIP SENSOR FOR 3150 FDA UDI
- Model / Reference
- PKG ASSY, 8000Q2 WITH 3150I ADAPTER CABLE EUDAMED114239-001 EUDAMED8000Q2 FDA UDI
- Description
- EAR CLIP SENSOR FOR 3150 FDA UDI
Identifiers
- Catalog Number
- 114239-001 FDA UDI
- Primary DI / UDI-DI
- 00849686050936 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849686050936 EUDAMED
- 510(k) Number
- K080255 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
8000Q2 Reusable Ear Clip 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
- Spo2 sensor — Orantech Inc. · Class IIb
- 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-00849686050936 | 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 9c848690-868c-4c17-9872-415e09fe82b6 61 fields · synced Jun 18, 2026
- FDA UDI 2d4a480b-27e0-4c88-ae45-2fe43d77a9b5 35 fields · synced May 29, 2026