Identity
- Trade Name
- RXi® Cable FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Device Name
- RXi Siemens Cathcor Ps Cable, p/n 301585-002 FDA UDI
- Model / Reference
- 018059 EUDAMEDFDA UDIRXi Accessories EUDAMED
- Description
- RXi Siemens Cathcor Ps Cable, p/n 301585-002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716102070 EUDAMED30841716102074 FDA 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cardiac catheterization laboratory computer
RXi® Cable by ACIST Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac catheterization laboratory computer.
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- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
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- OptoMonitor 3 — Opsens · Class II
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Cleared under the same submission
K132474 also covers:
- ACIST Navvus® Catheter — ACIST Medical Systems, Inc.
- ACIST RXi® Ao Interface Box — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
- RXi® Cable — ACIST Medical Systems, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
Sources (2)
- FDA UDI d1c642ab-3763-4047-865a-10fa07f2b939 34 fields · synced Jul 30, 2026
- EUDAMED 82411f61-0595-45f3-bbc8-1529e28b9d9d 61 fields · synced Jul 30, 2026