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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 ?
510(k)
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.
FDA-Cleared Indications
- Used to deliver oxygen in medical settings.
- Used as oxygen-conveying tubing with vinyl and latex tip components.
Clinical Applications
- Connecting an oxygen source to a patient oxygen-delivery interface when compatible with the prescribed system.
- Providing oxygen tubing for routine clinical oxygen administration.
- Use in healthcare environments requiring a flexible oxygen conduit.
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.
Practical Considerations
- Confirm the tubing diameter, connector type, and length are compatible with the oxygen source and delivery interface.
- The device contains vinyl and latex components; review latex-allergy risk before use and select a latex-free alternative when appropriate.
- Use only for oxygen delivery as labeled; do not assume compatibility with ECMO, extracorporeal circuits, portal-vein devices, or other specialized systems without manufacturer documentation.
- Inspect packaging and tubing for damage, contamination, kinks, or obstruction before use.
- MRI compatibility is not established by the available FDA record; determine safety from the complete product labeling and the connected oxygen-delivery system.
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.