Identity
- Trade Name
- IntelliVue FMS-4 EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module rack FDA UDI
- Device Name
- IntelliVue Module Racks EUDAMEDThe IntelliVue FMS-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder. FDA UDI
- Model / Reference
- 865243 EUDAMEDIntelliVue FMS-4 FDA UDI
- Description
- The IntelliVue FMS-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder. FDA UDI
Identifiers
- Catalog Number
- 865243 FDA UDI
- Primary DI / UDI-DI
- 00884838029279 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838029279 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module rack 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
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 Unsafe FDA UDI
IntelliVue FMS-4 by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00884838029279 | 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 dc74f8c2-e8a3-40ef-83a4-fe1b89fe74fc 61 fields · synced Oct 6, 2026
- FDA UDI 5e213aee-f75c-4201-b185-cbdb459f9fa2 36 fields · synced May 30, 2026