Identity
- Trade Name
- RXi Cart EUDAMEDACIST RXi® Cart FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Device Name
- RXi Cart, p/n 701606-001 FDA UDI
- Model / Reference
- RXi Accessories EUDAMED018111 EUDAMEDFDA UDI
- Description
- RXi Cart, p/n 701606-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716100595 EUDAMEDFDA UDI
- Basic UDI-DI
- 08417161000006FX EUDAMED
- 510(k) Number
- K132474 FDA UDI
- FDA Product Code
- OBI FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Cardiac catheterization laboratory computer 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RXi Cart by ACIST Medical Systems, 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 | 08417161000006FX | 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 4d07f2b3-6aac-463a-8a57-1d8432ed3d00 61 fields · synced Jul 15, 2026
- FDA UDI 1d787487-5a2a-4daa-abaa-2c4f8d700c09 34 fields · synced May 30, 2026