Identity
- Trade Name
- Horizon XVu FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Device Name
- Computerized Hemodynamic monitoring System FDA UDI
- Model / Reference
- Lite_115V FDA UDI
- Description
- Computerized Hemodynamic monitoring System FDA UDI
Identifiers
- Catalog Number
- 960-800-315 FDA UDI
- Primary DI / UDI-DI
- 07290102932788 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac catheterization laboratory computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac catheterization laboratory computer
Horizon XVu by Mennen Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac catheterization laboratory computer.
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- McKesson Cardiology Hemo — Change Healthcare Canada Company · Class II
- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
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
- Mennen Medical, Inc.
Sources (1)
- FDA UDI e5fe5f3a-541c-4760-b5b8-7305fb1e4344 35 fields · synced May 31, 2026