LiDCOunity v2 Hemodynamic Monitor
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by LiDCO Ltd
Identity
- Trade Name
- LiDCOunity v2 monitor EUDAMEDLiDCO Ltd FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- LiDCOunity v2 Hemodynamic Monitoring System EUDAMEDLiDCOunity Hemodynamic Assembly, Combined functionality, comprising of: FDA UDI
- Model / Reference
- HM 92-03 ASSEMBLY EUDAMEDFDA UDIHM 92-01 Assembly EUDAMED
- Description
- LiDCOunity Hemodynamic Assembly, Combined functionality, comprising of: FDA UDI
Identifiers
- Catalog Number
- HM 92-03 ASSEMBLY FDA UDI
- Primary DI / UDI-DI
- 05060110522224 EUDAMEDFDA UDI
- Basic UDI-DI
- 506011052000Z7T3C01V000BD EUDAMED
- Direct Marketing DI
- 05060110522224 EUDAMED
- 510(k) Number
- FDA Product Code
- DXG FDA 510(k)FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1435 FDA 510(k)
- Regulation Number
- 870.1435 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
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
The LiDCOunity v2 Hemodynamic Monitor is a pre-programmed, single-function diagnostic computer designed to measure and monitor hemodynamic parameters. Classified as a Class II device, it provides real-time assessment of cardiac output, stroke volume variation, and other critical hemodynamic variables to support clinical decision-making in cardiovascular care.
This device is intended for use in hospital settings, including intensive care units and operating rooms, and is supplied as a reusable medical instrument. It operates without MRI compatibility restrictions and requires proper calibration and maintenance as outlined in its instructions. Authorized under FDA 510(k) clearance, MDD, and MDR compliance, the LiDCOunity v2 is regulated under the classification code 870.1435 and registration number 9615817.
Frequently asked questions
Is the LiDCOunity v2 Hemodynamic Monitor designed for use in MRI environments, and if not, why not?
No, the LiDCOunity v2 Hemodynamic Monitor is explicitly stated to have no MRI compatibility restrictions. This means it should not be used in MRI environments, as its operation or safety in such settings has not been validated or approved.
How is the LiDCOunity v2 Hemodynamic Monitor supplied, and is it intended for single-use or reusable applications?
The LiDCOunity v2 is supplied as a reusable medical instrument, meaning it is designed for repeated use in clinical settings like intensive care units and operating rooms. Reusability requires adherence to the manufacturer’s calibration and maintenance protocols to ensure accuracy and safety.
What types of hemodynamic parameters does the LiDCOunity v2 monitor, and where is it primarily intended for use?
The device measures and monitors cardiac output, stroke volume variation, and other critical hemodynamic variables in real-time. It is specifically intended for use in hospital settings, including intensive care units (ICUs) and operating rooms, to support clinical decision-making in cardiovascular care.
What regulatory pathways has the LiDCOunity v2 Hemodynamic Monitor followed, and what classification does it hold?
The device has undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance processes. It is classified as a Class II device under the FDA’s classification code 870.1435, indicating a moderate risk level requiring regulatory oversight.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163334 | Class II | Active |
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Manufacturer
- Manufacturer
- LiDCO Ltd
- FDA Applicant
- Lidco, Ltd.
Sources (3)
- FDA 510(k) K163334 24 fields · synced Sep 18, 2026
- FDA UDI 5cd7b2ba-28e9-4538-9722-a799044ed8d2 36 fields · synced May 29, 2026
- EUDAMED 232e4cd0-7f44-404f-9ef1-70de018b4b74 61 fields · synced Jul 22, 2026