Identity
- Trade Name
- ICE PIM EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- ICE PIM EUDAMEDIntracardiac echocardiography (ICE) patient interface module (PIM) FDA UDI
- Model / Reference
- VSICEPIM EUDAMEDFDA UDI
- Description
- Intracardiac echocardiography (ICE) patient interface module (PIM) FDA UDI
Identifiers
- Catalog Number
- VSICEPIM FDA UDI
- Primary DI / UDI-DI
- 00845225013011 EUDAMED00845225012854 FDA UDI
- Basic UDI-DI
- 08452250BM1656Z2 EUDAMED
- Direct Marketing DI
- 00845225013011 EUDAMED
- 510(k) Number
- K200812 FDA UDI
- FDA Product Code
- OBJ FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Ice Pim by Philips Image Guided Therapy Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08452250BM1656Z2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 9bc7d5dd-10f1-4061-b2e9-af01f9de3084 61 fields · synced Jul 10, 2026
- FDA UDI 9b77f18b-2fb0-4955-9c28-1d61d7683395 37 fields · synced May 30, 2026