Identity
- Trade Name
- RXi® Mini Navvus Interface Cable FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Device Name
- Navvus Interface to Processing Unit Cable, p/n 301883-003 FDA UDI
- Model / Reference
- 018596 FDA UDI
- Description
- Navvus Interface to Processing Unit Cable, p/n 301883-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30841716101817 FDA UDI
- 510(k) Number
- K172216 FDA UDI
- FDA Product Code
- DRQ FDA UDI
- GMDN Term
- Cardiac catheterization laboratory computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Cardiac catheterization laboratory computer
RXi® Mini Navvus Interface Cable by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- OptoMonitor 3 — Opsens · Class II
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- OptoMonitor 3 — Opsens · Class II
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- OptoMonitor 3 — Opsens · Class II
Cleared under the same submission
K172216 also covers:
- ACIST RXi® Mini Mount — ACIST Medical Systems, Inc.
- ACIST RXi® Mini Navvus Interface — ACIST Medical Systems, Inc.
- ACIST RXi® Mini Processing Unit — ACIST Medical Systems, Inc.
- ACIST RXi® Mini System Overpack — ACIST Medical Systems, Inc.
- ACIST RXi® Mini System Overpack — ACIST Medical Systems, Inc.
- RXi® Mini Navvus Interface Cable — ACIST Medical Systems, Inc.
- RXi® Mini Navvus Interface Cable — ACIST Medical Systems, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
Sources (1)
- FDA UDI c7e48105-8ff0-42d7-8202-c2df69dbcdc2 34 fields · synced Jun 8, 2026