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paediatric face mask 1-3 w wo ring
Warne Surgical Products
Summary: The paediatric face mask 1-3 w wo ring is a medical device used primarily in pediatric anesthesia to deliver gases to young patients. It is typically used by anesthesiologists and other healthcare providers in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K834454 ↗
Decision Date
January 18, 1984
Product Code
BSJ
Device Class
Class 1
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on January 18, 1984, by Warne Surgical Products. It is classified as a Class 1 device under product code BSJ.
What It Is
The paediatric face mask 1-3 w wo ring is designed to fit the facial contours of young children, ensuring effective delivery of anesthetic gases. It may come with or without a ring to attach to anesthesia circuits. The mask is typically made of soft, pliable materials to provide comfort and a secure fit during procedures.
Clinical Applications
This device is commonly used in pediatric anesthesia to administer inhalational anesthetics during surgeries or other medical procedures. It is particularly useful in settings such as hospitals and surgical centers where pediatric patients require sedation or anesthesia. Anesthesiologists and pediatricians are the primary users of this device.
Indications for Use
The device is indicated for use in delivering anesthetic gases to pediatric patients, typically those aged 1 to 3 years. It is used in situations where non-invasive ventilation support is needed during surgical procedures.
Practical Considerations
The mask is available in sizes suitable for children aged 1 to 3 years, ensuring a snug fit to minimize gas leakage. It is compatible with standard anesthesia machines and circuits. Clinicians should ensure proper sizing and fit to optimize effectiveness and patient comfort.
Related Literature
The linked study compared weight-based and external ear-size based techniques for selecting laryngeal mask airways in pediatric patients. While specific findings are not detailed, such studies typically aim to optimize airway management in children. Limitations include the lack of an abstract and publication year, which restricts detailed analysis.
Frequently Asked Questions
What is the paediatric face mask 1-3 w wo ring used for?
It is used to deliver anesthetic gases to pediatric patients during surgical procedures.
What specialties typically use this device?
Anesthesiologists and pediatricians commonly use this device in surgical and hospital settings.
What are the FDA-cleared indications?
The device is indicated for delivering anesthetic gases to pediatric patients, particularly those aged 1 to 3 years, during medical procedures.
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.