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NUVISION Connector Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref FG10594Model NUVISION Ultrasound Connector Cable
Identity
- Trade Name
- NUVISION Connector Cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- NUVISION Ultrasound Connector Cable EUDAMEDThe NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system. FDA UDI
- Model / Reference
- NUVISION Ultrasound Connector Cable EUDAMEDFG10594 EUDAMEDFDA UDI
- Description
- The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system. FDA UDI
Identifiers
- Catalog Number
- FG10594 FDA UDI
- Primary DI / UDI-DI
- 00860005688111 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0043F7 EUDAMED
- Direct Marketing DI
- 00860005688111 EUDAMED
- FDA Product Code
- OBJ FDA UDI
- EMDN Code
- Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - 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
- Belgium 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
NUVISION Connector Cable by Biosense Webster Inc — 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 | 08468350a0043F7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biosense Webster, Inc
- EUDAMED SRN
- US-MF-000014219
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (2)
- EUDAMED 6b1404bc-38c9-4f9a-980e-c58b4b6e0141 61 fields · synced Jul 9, 2026
- FDA UDI f7518071-741e-4586-a115-eea6871c66df 36 fields · synced May 27, 2026