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portex blue line ultra paediatric tracheosomy tube
Smiths Medical Asd
Summary: The Portex Blue Line Ultra Pediatric Tracheostomy Tube is a medical device used to maintain an open airway in pediatric patients requiring long-term ventilation. It is primarily used by pediatric specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K170720 ↗
Decision Date
December 7, 2017
Product Code
JOH
Device Class
Class 2
Evidence
0 studies
The Portex Blue Line Ultra Pediatric Tracheostomy Tube, manufactured by Smiths Medical, was cleared via the FDA 510(k) pathway on December 7, 2017. It is classified as a Class 2 device under product code JOH.
What It Is
The Portex Blue Line Ultra Pediatric Tracheostomy Tube is designed for pediatric patients who need a secure airway for ventilation. It features a soft, flexible tube that is inserted into the trachea through a stoma in the neck. The device helps maintain airway patency and is often used in patients with chronic respiratory conditions or those requiring long-term mechanical ventilation.
Clinical Applications
This tracheostomy tube is commonly used in pediatric intensive care units and by pediatric otolaryngologists. It is suitable for children with obstructive airway conditions, neuromuscular disorders, or those who are ventilator-dependent. The device is crucial in managing airway stability in both acute and chronic settings.
Indications for Use
The device is indicated for pediatric patients who require a tracheostomy for airway management. This includes children with conditions that obstruct normal breathing or those needing prolonged mechanical ventilation.
Practical Considerations
The Portex Blue Line Ultra Pediatric Tracheostomy Tube comes in various sizes to accommodate different pediatric anatomies. It is important to select the appropriate size for each patient to ensure effective ventilation and minimize complications. Compatibility with standard ventilator connections is a key feature.
Frequently Asked Questions
What is the Portex Blue Line Ultra Pediatric Tracheostomy Tube used for?
It is used to maintain an open airway in pediatric patients who require long-term ventilation or have obstructive airway conditions.
What specialties typically use this device?
Pediatric intensive care specialists and pediatric otolaryngologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for pediatric patients needing a tracheostomy for airway management, particularly those with obstructive airway conditions or requiring prolonged mechanical ventilation.
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.