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
510K
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.
Clinical Applications
These kits are commonly used in operating rooms, intensive care units, and other clinical settings where patient ventilation needs to be monitored closely. They are essential in procedures involving anesthesia, where precise monitoring of respiratory gases is critical. The device is used across various patient populations, including pediatric and adult patients, to ensure effective ventilation management.
Indications for Use
The FDA indications suggest that these kits are intended for use in procedures requiring the sampling and analysis of respiratory gases. They are particularly useful in settings where accurate gas monitoring is necessary, such as during anesthesia or in critical care.
Practical Considerations
These kits are typically compatible with standard respiratory equipment and are designed for single-use to maintain sterility. Clinicians should ensure proper connection to the gas sampling line to avoid leaks and ensure accurate readings.
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.