Identity
- Trade Name
- FARASTAR™ EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- FARASTAR Catheter Connection Cables EUDAMEDCatheter Connection Cable FDA UDI
- Model / Reference
- M004PF41M444 EUDAMEDFDA UDI
- Description
- Catheter Connection Cable FDA UDI
Identifiers
- Catalog Number
- M004PF41M444 FDA UDI
- Primary DI / UDI-DI
- 00191506041663 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000670NK EUDAMED
- PMA Number
- P230030 FDA UDI
- FDA Product Code
- QZI FDA UDI
- EMDN Code
- C020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Farastar™ by Boston Scientific 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 | 01915060000000000000670NK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED b22a4926-5d4b-4ffc-bee3-cf518f726a18 61 fields · synced Oct 6, 2026
- FDA UDI 83bd30b8-f552-4d3d-8a81-5df62b56d1e3 35 fields · synced May 29, 2026