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CVi X-Ray Interface Cable (Philips Integris)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 017394Model CVi Accessories
Identity
- Trade Name
- CVi X-Ray Interface Cable (Philips Integris) EUDAMEDCVi® Cable FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- CVi interface cable, p/n 700402-003 FDA UDI
- Model / Reference
- CVi Accessories EUDAMED017394 EUDAMEDFDA UDI
- Description
- CVi interface cable, p/n 700402-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30841716101077 EUDAMEDFDA UDI
- Basic UDI-DI
- 08417161000003FR EUDAMED
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CVi X-Ray Interface Cable (Philips Integris) by ACIST Medical Systems, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 08417161000003FR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000010784
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (2)
- EUDAMED 4b2f94bd-697a-4ac6-beac-8cd1c5dd538e 61 fields · synced Jul 28, 2026
- FDA UDI 408512aa-f480-4a8a-a949-f655c3505eb2 33 fields · synced May 30, 2026