Fluido Compact Blood And Fluid Warming System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211618 FDA 510(k)
- FDA Product Code
- LGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fluido Compact Blood And Fluid Warming System is a thermal infusion fluid warmer. It is designed to help prevent hypothermia in patients by warming blood products or IV fluids prior to administration.
The system is intended for use in a healthcare environment, including adult and pediatric patients weighing 3.5 kg or more. It is maintenance-free and designed for durability. The device has received FDA 510K authorization.
Frequently asked questions
What is the Fluido Compact Blood and Fluid Warming System used for?
The Fluido Compact Blood and Fluid Warming System is used to warm blood products or IV fluids prior to administration to help prevent hypothermia in patients.
What type of patients can the Fluido Compact Blood and Fluid Warming System be used for?
The system is intended for use in adult and pediatric patients weighing 3.5 kg or more in a healthcare environment.
Is the Fluido Compact Blood and Fluid Warming System maintenance-free?
Yes, the Fluido Compact Blood and Fluid Warming System is designed to be maintenance-free and durable.
What authorization has the Fluido Compact Blood and Fluid Warming System received?
The Fluido Compact Blood and Fluid Warming System has received FDA 510K authorization.
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. Sources consulted: Fluido Compact - TSC Life, PDF Fluido Compact Blood and Fluid Warming TM-US - INT/R1008, Fluido@ Blood and Fluid Warming - TSC Life - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211618 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Surgical Company International B.V.
Sources (1)
- FDA 510(k) K211618 24 fields · synced Oct 6, 2026