Bonhawa Respiratory Humidifier
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223863 FDA 510(k)
- FDA Product Code
- BTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5450 FDA 510(k)
- Regulation Number
- 868.5450 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bonhawa Respiratory Humidifier is a medical device classified as a Humidifier, Respiratory Gas, (Direct Patient Interface). It is designed to add moisture to respiratory gases, such as oxygen or air, to prevent airway dryness and maintain patient comfort during inhalation therapy. This device is intended for use in clinical settings where respiratory support is administered, including anesthesia and critical care environments.
The Bonhawa Respiratory Humidifier is supplied as a single-use or reusable device, depending on the model variant, and is regulated under FDA 510K and MDR authorizations. It is intended for direct patient interface applications and must be used in accordance with manufacturer instructions for proper setup, sterilization (if reusable), and storage. The device is categorized under Device Class II and adheres to regulatory standards outlined in 21 CFR 868.5450. Multiple model references are listed, ensuring compatibility with various respiratory therapy systems.
Frequently asked questions
What clinical environments is the Bonhawa Respiratory Humidifier primarily intended for use in?
The Bonhawa Respiratory Humidifier is designed for clinical settings where respiratory support is administered, specifically in anesthesia and critical care environments. Its purpose is to add moisture to respiratory gases like oxygen or air to prevent airway dryness and maintain patient comfort during inhalation therapy.
Are there single-use and reusable variants of the Bonhawa Respiratory Humidifier, and how should reusable models be handled?
Yes, the Bonhawa Respiratory Humidifier is available in both single-use and reusable variants. For reusable models, proper sterilization must be performed as instructed by the manufacturer to ensure safety and functionality before each use.
What regulatory pathways does the Bonhawa Respiratory Humidifier follow, and what does this mean for its use?
The Bonhawa Respiratory Humidifier is regulated under both FDA 510K and MDR (Medical Device Regulation) authorizations, indicating it has undergone review for safety and performance. This means it adheres to strict regulatory standards, including 21 CFR 868.5450, ensuring compliance for use in direct patient interface applications.
How do I determine which model of the Bonhawa Respiratory Humidifier is compatible with my respiratory therapy system?
The Bonhawa Respiratory Humidifier comes in multiple model references, each designed for compatibility with various respiratory therapy systems. The manufacturer’s documentation or support team should be consulted to confirm the correct model for your specific system, as the exact specifications or sizing details are not provided in the data.
What should I consider when storing the Bonhawa Respiratory Humidifier to ensure its proper function?
While specific storage instructions are not detailed in the provided data, reusable models require adherence to manufacturer guidelines for cleaning, sterilization, and storage to maintain functionality and hygiene. Single-use models should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223863 | Class II | Active |
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Manufacturer
- Manufacturer
- Telesair, Inc
- FDA Applicant
- Telesair, Inc.
Sources (2)
- FDA 510(k) K223863 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026