Identity
- Trade Name
- IntelliVue Patient Monitor MX400 EUDAMEDIntelliVue MX400 Patient Monitor FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- MX400-550 EUDAMEDThe IntelliVue MX400 patient monitor is operated primarily via touch screen. It has an integrated 9" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The IntelliVue MX400 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor highly portable. FDA UDI
- Model / Reference
- 866060 EUDAMEDIntelliVue Patient Monitor MX400 FDA UDI
- Description
- The IntelliVue MX400 patient monitor is operated primarily via touch screen. It has an integrated 9" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030). The IntelliVue MX400 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor highly portable. FDA UDI
Identifiers
- Catalog Number
- 866060 FDA UDI
- Primary DI / UDI-DI
- 00884838038752 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM589TV EUDAMED
- Direct Marketing DI
- 00884838038752 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Austria 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
IntelliVue Patient Monitor MX400 by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM589TV | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED b814443c-c677-4c61-9b73-2811e250444c 61 fields · synced Oct 6, 2026
- FDA UDI 22892b9a-e8d0-46c0-a366-237064e2ea04 36 fields · synced May 30, 2026