đź“‹ FDA Reference
Venturi Mask W Humdification Cup Adult Paediatric
Dhd Medical Products Div. Diemolding
Summary: The Venturi Mask with Humidification Cup is a respiratory device used to deliver precise oxygen concentrations to patients. It is commonly used by respiratory therapists and clinicians in both adult and pediatric populations.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860874 ↗
Decision Date ?
March 19, 1986
Product Code ?
BYF
Device Class ?
Class 1
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on March 19, 1986. Manufactured by Dhd Medical Products, it is classified as a Class 1 device under product code BYF.
What It Is
The Venturi Mask with Humidification Cup is a medical device designed to deliver controlled oxygen concentrations to patients. It uses the Venturi principle to mix oxygen with room air, allowing for precise delivery of oxygen percentages. The humidification cup adds moisture to the oxygen, making it more comfortable for patients, especially those with dry airways.
FDA-Cleared Indications
- Delivery of controlled concentrations of supplemental oxygen to spontaneously breathing patients.
- Administration of oxygen through a Venturi mask for patients who require a specified oxygen concentration.
- Humidification of delivered oxygen when added moisture is clinically appropriate.
- Use in adult and pediatric patients with compatible oxygen-therapy requirements.
Clinical Applications
- Controlled oxygen therapy for spontaneously breathing hospital patients.
- Oxygen delivery when maintaining a specified inspired oxygen concentration is important.
- Humidified oxygen delivery for patients who experience airway or nasal dryness during oxygen therapy.
- Use in respiratory-care settings for adult and pediatric patients, with the appropriate mask and Venturi adapter.
Practical Considerations
- Select the correct mask size, Venturi adapter, and oxygen flow setting for the patient's age, anatomy, and prescribed oxygen concentration.
- The mask must fit securely without obstructing breathing; leaks can alter the delivered oxygen concentration.
- Connect the device only to a compatible oxygen source and follow the manufacturer's instructions for the humidification cup, tubing, and water.
- This is intended for spontaneously breathing patients and does not provide ventilatory support; patients with inadequate ventilation may require another therapy.
- The mask and humidification cup are generally not MRI-compatible equipment unless the specific components are labeled for MRI use. Remove metallic or unsafe accessories before an MRI examination.
Frequently Asked Questions
What is the Venturi Mask with Humidification Cup used for?
It is used to deliver precise oxygen concentrations to patients, often those with respiratory conditions like COPD or asthma.
What specialties typically use this device?
Respiratory therapists and clinicians in critical care and pulmonary medicine commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients needing controlled oxygen therapy, particularly those with chronic or acute respiratory conditions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.