AirGuard System
by The Surgical Company International BV (As Tsc Life)
510(k) K251733
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK251733 | Date4 Sep 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Fluido® AirGuard System
- 510(k) Number
- FDA Product Code
- LGZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The AirGuard System is a Warmer, Thermal, Infusion Fluid designed to maintain and regulate the temperature of intravenous fluids during administration. It ensures fluid warmth to enhance patient comfort and therapeutic efficacy, particularly in critical care settings where rapid infusion is required.
This device is intended for use in general hospital environments and is supplied as a reusable system. It is not MRI-safe and requires proper storage and handling to preserve functionality. Authorized under FDA 510(k) clearance and MDR, it adheres to regulatory standards for infusion fluid warming in clinical practice.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Fluido® AirGuard System in clinical settings?
The Fluido® AirGuard System is designed to maintain and regulate the temperature of intravenous fluids during administration. Its purpose is to ensure fluids remain warm, which enhances patient comfort and improves therapeutic efficacy—particularly important in critical care settings where rapid infusion is required.
Is the Fluido® AirGuard System reusable or single-use, and how should it be handled?
The Fluido® AirGuard System is explicitly supplied as a reusable device. Proper storage and handling are required to preserve its functionality, as noted in the manufacturer’s instructions. Reuse must comply with facility protocols for cleaning, disinfection, and maintenance to ensure safety and performance.
Can the Fluido® AirGuard System be used in an MRI environment, and if not, what are the implications?
No, the Fluido® AirGuard System is not MRI-safe. This means it should not be used in or near MRI machines, as exposure to magnetic fields could compromise its structural integrity or functionality. Clinicians must ensure the device is removed from the patient and the MRI environment before imaging.
What regulatory pathways has the Fluido® AirGuard System followed, and where is it authorized for use?
The device has been authorized through FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It is intended for use in general hospital environments, as reflected in its submission to the FDA’s General Hospital advisory committee (HO). These pathways confirm its compliance with U.S. and EU standards for infusion fluid warming systems.
Are there multiple models or sizes available for the Fluido® AirGuard System, and if so, how are they differentiated?
The provided data lists multiple FEI numbers (e.g., 3030125051, 3002930098), which typically correspond to different product variants or configurations within the same device family. While exact specifications (e.g., flow rates, warming capacities) aren’t detailed here, these identifiers suggest the system may offer modularity or customization for varying clinical needs. Contacting the manufacturer would clarify available models or sizing options.