Identity
- Trade Name
- Cardiac Output Parameter Module EUDAMEDPatient Monitor Module Cardiac Output FDA UDI
- Generic Name
- Patient monitoring system module, cardiac output FDA UDI
- Device Name
- Cardiac Output Module EUDAMEDCardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. Supports either preloaded syringes or flow-through (CO-Set) technique. FDA UDI
- Model / Reference
- 862279 EUDAMEDCardiac Output Parameter Module FDA UDI
- Description
- Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. Supports either preloaded syringes or flow-through (CO-Set) technique. FDA UDI
Identifiers
- Catalog Number
- 862279 FDA UDI
- Primary DI / UDI-DI
- 00884838020948 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838020948 EUDAMED
- FDA Product Code
- DRT FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Patient monitoring system module, cardiac output FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 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
Cardiac Output Parameter Module by Philips Medizin Systeme Böblingen GmbH — 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-00884838020948 | 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 9dd2cd7c-234a-4408-a1b7-e1c437725f6f 61 fields · synced Jun 19, 2026
- FDA UDI 8f2397da-3f31-4be9-b28c-b90c6faecb79 36 fields · synced May 30, 2026