Wireless SpO2 3.0 Module (Networks 6-10)
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Wireless SpO2 3.0 Module (Networks 6-10) EUDAMEDExpression MR Wireless SpO2 Patient Module (Gen 3)6-10 FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- Expression MR400 MRI Patient Monitor Sys EUDAMED3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10). FDA UDI
- Model / Reference
- 989803194331 EUDAMEDWireless SpO2 3.0 Module (Networks 6-10) FDA UDI
- Description
- 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 6-10). FDA UDI
Identifiers
- Catalog Number
- 989803194331 FDA UDI
- Primary DI / UDI-DI
- 00884838055032 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838055032 EUDAMED
- FDA Product Code
- MWI 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
- 870.2300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
Yes
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
For the Wireless SpO2 3.0 Module (Networks 6-10), this medical device directory provides detailed information on its specifications, features, and regulatory compliance. By understanding its capabilities and limitations, healthcare professionals can make informed decisions when selecting a wireless monitoring system for their patients.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838055032 | 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 d01a9a18-f837-45c6-b6b5-2613ebac58e9 61 fields · synced Oct 6, 2026
- FDA UDI 7cc72769-46ba-44fd-9cc6-ac86d5a9833b 36 fields · synced May 25, 2026