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oxygen tubing w vinyl and latex tips
Airlife
Summary: The oxygen tubing with vinyl and latex tips by Airlife is a Class 1 medical device cleared by the FDA for use in portal-vein-related procedures. Key evidence highlights the use of PVC tubing in various clinical settings, with studies focusing on safety and material exposure.
FDA Clearance Information
Pathway 510K
Number K790160 ↗
Decision Date February 8, 1979
Product Code BYX
Device Class Class 1
Evidence 0 studies
The oxygen tubing with vinyl and latex tips by Airlife was cleared through the FDA 510(k) pathway on February 8, 1979. It is classified as a Class 1 device under product code BYX.
What It Is
This device consists of oxygen tubing with vinyl and latex tips, designed for use in medical settings to deliver oxygen. It is primarily used in procedures involving portal-vein devices, providing a reliable conduit for oxygen delivery.
Clinical Applications
Commonly used in scenarios requiring oxygen delivery, such as during extracorporeal membrane oxygenation (ECMO) and other procedures involving portal-vein devices. It is essential in maintaining oxygenation in critical care settings.
Evidence Summary
The literature includes 9 studies, ranging from 2011 to 2018, with various study designs including RCTs, prospective, and retrospective analyses. These studies explore the use of PVC tubing in clinical settings, focusing on safety and material exposure.
Reported Outcomes
Published studies report that the use of PVC tubing in ECMO and other clinical settings is effective in delivering oxygen. However, there is concern about exposure to plasticizers like DEHP, prompting recommendations for alternative materials.
Safety Profile
Reported complications include potential exposure to diethylhexylphthalate (DEHP), a plasticizer used in PVC tubing. Studies suggest that while effective, the safety of alternative plasticizers in ECMO situations remains under-evaluated.
Evidence Limitations
The evidence is limited by the lack of comprehensive evaluation of alternative plasticizers in clinical settings. Further research is needed to assess the long-term safety and efficacy of these materials in oxygen delivery systems.
Frequently Asked Questions
What are the clinical indications for oxygen tubing w vinyl and latex tips?
The device is indicated for use in procedures involving portal-vein devices, primarily for oxygen delivery.
What outcomes have been reported in clinical studies?
Studies report effective oxygen delivery but highlight concerns about exposure to DEHP plasticizers.
What complications have been reported?
Safety data indicate potential exposure to DEHP, with a need for evaluation of alternative plasticizers.
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.