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AeroEclipse ONE BAN

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200063

by Trudell Medical International

Identifiers

510(k) Number
K200063 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AeroEclipse ONE BAN is a nebulizer designed for direct patient interface, classified under product code CAF. It delivers aerosolized medication to patients via inhalation, facilitating respiratory therapy for conditions requiring precise medication administration.

This device is intended for single-use and is supplied sterile. It operates in clinical settings such as anesthesia and respiratory care, with regulatory authorizations including FDA 510(k) clearance and MDR compliance. The device is reusable only after proper cleaning and sterilization, adhering to manufacturer guidelines for reprocessing.

Frequently asked questions

Is the AeroEclipse ONE BAN designed for use in anesthesia or general respiratory therapy, and how does that affect its application?

The AeroEclipse ONE BAN is primarily intended for direct patient interface in clinical settings like anesthesia and respiratory care, as indicated by its classification under product code CAF and its advisory committee designation (Anesthesiology). This means it’s optimized for precise medication delivery during procedures where controlled aerosolized therapy is critical, such as during anesthesia induction or ventilation support.

How should I handle the AeroEclipse ONE BAN after use—can it be reused, and if so, what steps are required?

The AeroEclipse ONE BAN is intended for single-use when supplied sterile, but it can be reused after proper cleaning and sterilization if reprocessed according to the manufacturer’s guidelines. This ensures compliance with clinical standards while extending the device’s lifespan in controlled environments like hospitals or respiratory therapy units.

What regulatory pathways has the AeroEclipse ONE BAN followed, and does that impact its use in different markets?

The device holds FDA 510(k) clearance (K200063) and MDR compliance, meaning it meets U.S. and EU regulatory standards for safety and performance. These authorizations confirm its suitability for use in both markets, though clinicians should always verify local guidelines for specific protocols or restrictions.

Is the AeroEclipse ONE BAN compatible with all nebulized medications, or are there specific considerations for its use?

While the AeroEclipse ONE BAN is designed to deliver aerosolized medication via inhalation, its compatibility with specific medications isn’t detailed in the provided data. Clinicians should consult the manufacturer’s instructions or medication compatibility guides to ensure proper use, as some formulations may require adjustments in delivery settings or device attachment.

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: AEROECLIPSE* XL BAN* Nebulizer | trudellmed.com, K200063 FDA 510 (k) - AeroEclipse* ONE BAN, TRUDELL MEDICAL INTERNATIONAL AEROECLIPSE II BAN QUICK ... - ManualsLib

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trudell Medical International

Sources (2)

  • FDA 510(k) K200063 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026