đź“‹ FDA Reference
Disposable Gas Sampling Interface Kits
Marquest Medical Products
Summary: Disposable gas sampling interface kits are used for collecting and analyzing respiratory gases. They are commonly used by anesthesiologists and respiratory therapists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K960972 ↗
Decision Date ?
October 18, 1996
Product Code ?
CCK
Device Class ?
Class 2
Evidence ?
0 studies
The disposable gas sampling interface kits by Marquest Medical Products were cleared through the FDA 510(k) pathway on October 18, 1996. It is classified as a Class 2 medical device.
What It Is
This device is a disposable kit designed for the collection and analysis of respiratory gases. It works by providing a sterile interface for gas sampling, which is crucial in monitoring and managing patient ventilation. The device is typically used in conjunction with other respiratory equipment to ensure accurate gas analysis.
FDA-Cleared Indications
- Collection and analysis of respiratory gases.
- Use as an interface between the patient breathing circuit or airway and respiratory gas monitoring equipment.
Clinical Applications
- Sampling respiratory gases during general anesthesia.
- Monitoring ventilation in intensive care and other critical-care settings.
- Connecting respiratory gas sampling lines to compatible monitoring or anesthesia equipment.
- Respiratory gas monitoring in adult and pediatric patients when the kit is appropriately sized and labeled for the patient and equipment.
Practical Considerations
- These are generally single-use disposable components; follow the specific product labeling for sterility, reuse, and disposal.
- Confirm connector compatibility with the anesthesia machine, ventilator, gas analyzer, sampling line, and patient circuit before use.
- Choose components appropriate for the patient population and airway or breathing circuit configuration, including pediatric or adult applications when available.
- Check all connections for leaks, kinks, obstruction, condensation, and incorrect placement because these can alter gas-sampling results.
- MRI safety is not established from the available FDA record. Confirm the kit's current labeling and the MRI compatibility of every connected component before use in an MRI environment.
Related Literature
The linked study explored a microfluidic approach for RNA extraction, highlighting the need for efficient sample pre-treatment in diagnostics. It presented a novel method using thermo-electric lysis and gel-electrophoretic purification, demonstrating improved RNA protection and extraction efficiency. However, the study focused on RNA extraction rather than gas sampling, limiting its direct applicability to the device in question.
Frequently Asked Questions
What is disposable gas sampling interface kits used for?
These kits are used for the collection and analysis of respiratory gases in clinical settings, ensuring accurate monitoring of patient ventilation.
What specialties typically use this device?
Anesthesiologists and respiratory therapists commonly use this device in operating rooms and intensive care units.
What are the FDA-cleared indications?
The kits are indicated for use in procedures requiring respiratory gas sampling and analysis, particularly during anesthesia and in critical care settings.
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.