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laerdal paediatric pocket mask model 820050
Laerdal Medical A/S
Summary: The Laerdal Paediatric Pocket Mask is a resuscitation device used to provide ventilation to infants and children. It is typically used by healthcare professionals in emergency settings.
FDA Clearance Information
Pathway
510K
Number
K023805 ↗
Decision Date
February 11, 2003
Product Code
CBP
Device Class
Class 2
Evidence
0 studies
The Laerdal Paediatric Pocket Mask was cleared through the FDA 510(k) pathway on February 11, 2003. Manufactured by Laerdal Medical A/S, it is classified as a Class 2 medical device.
What It Is
The Laerdal Paediatric Pocket Mask is a compact, portable mask designed to provide effective ventilation to pediatric patients during resuscitation. It features a one-way valve and a transparent dome to allow for proper seal and visibility. The mask is designed to be used in emergency situations where manual ventilation is required.
Clinical Applications
This device is commonly used in emergency departments, ambulances, and other acute care settings. It is particularly useful for pediatricians, emergency medical technicians, and other healthcare providers who may need to perform resuscitation on infants and children. The mask is suitable for use in situations such as respiratory arrest or failure, where immediate ventilation is critical.
Indications for Use
The FDA indications for the Laerdal Paediatric Pocket Mask include providing ventilation support to pediatric patients in emergency situations. It is intended for use on infants and children who require assistance with breathing.
Practical Considerations
The Laerdal Paediatric Pocket Mask is designed to fit a range of pediatric face sizes, ensuring a proper seal during use. It is compatible with standard ventilation equipment and can be used with or without supplemental oxygen. Proper technique is essential to ensure effective ventilation and patient safety.
Frequently Asked Questions
What is the Laerdal Paediatric Pocket Mask used for?
It is used to provide ventilation to infants and children during resuscitation in emergency situations.
What specialties typically use this device?
This device is typically used by emergency medical technicians, pediatricians, and other healthcare providers in acute care settings.
What are the FDA-cleared indications?
The device is indicated for providing ventilation support to pediatric patients in emergency situations.
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.