Identity
- Trade Name
- Wireless SP02 Module (Gen 2) EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- Wirelss Gating&Wirelss ECG/SpO2 Modules EUDAMEDAdditional or replacement wireless SpO2 module for use with the Expression MRI Patient Monitoring Systems. FDA UDI
- Model / Reference
- 989803163111 EUDAMEDWireless SP02 Module (Gen 2) FDA UDI
- Description
- Additional or replacement wireless SpO2 module for use with the Expression MRI Patient Monitoring Systems. FDA UDI
Identifiers
- Catalog Number
- 989803163111 FDA UDI
- Primary DI / UDI-DI
- 00884838046788 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838046788 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry 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
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
Wireless SP02 Module (Gen 2) 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-00884838046788 | 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 5c799acf-5baa-4142-8801-8463ab5341b4 61 fields · synced Oct 6, 2026
- FDA UDI d5830405-3c59-4133-8292-2c286285f881 36 fields · synced May 29, 2026