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Quick Connect SpO2 Probe, MRI
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803161991
Identity
- Trade Name
- Quick Connect SpO2 Probe, MRI EUDAMEDFDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Reusable SpO2 Probes EUDAMEDFiber Optic SpO2 Sensor for use with Wireless SpO2 Module (989803163111) and Quick Connect SpO2 accessories FDA UDI
- Model / Reference
- 989803161991 EUDAMEDQuick Connect SpO2 Probe, MRI FDA UDI
- Description
- Fiber Optic SpO2 Sensor for use with Wireless SpO2 Module (989803163111) and Quick Connect SpO2 accessories FDA UDI
Identifiers
- Catalog Number
- 989803161991 FDA UDI
- Primary DI / UDI-DI
- 00884838030817 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838030817 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Quick Connect SpO2 Probe, MRI by Invivo, a division of Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00884838030817 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 87972150-4979-45eb-8b19-aad9ef5dd025 61 fields · synced Oct 6, 2026
- FDA UDI 020dcba9-77eb-43ea-bfed-82676b6ca859 37 fields · synced May 30, 2026