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PiCCO Continuous Cardiac Output Cable, 4.1m
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref M1154585
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Patient monitoring system module, cardiac output FDA UDI
- Device Name
- PiCCO Continuous Cardiac Output Cable, 4.1m EUDAMED
- Model / Reference
- M1154585 EUDAMEDPiCCO Continuous Cardiac Output Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103039 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682103039 EUDAMED
- 510(k) Number
- K132528 FDA UDI
- FDA Product Code
- DXG FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, cardiac output FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1435 FDA UDI
- Market of Registration
- Finland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PiCCO Continuous Cardiac Output Cable, 4.1m by GE Healthcare Finland Oy — 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-00840682103039 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 118a0993-c26c-4995-a19b-5eccd827204f 61 fields · synced Oct 7, 2026
- FDA UDI 5698d15b-44d3-48b3-8161-c1881f94ee43 34 fields · synced May 29, 2026