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two-lumen central venous access kit with hemostasis valve side port
Arrow Intl.
Summary: The two-lumen central venous access kit with hemostasis valve side port is used for central venous catheterization, primarily by anesthesiologists and critical care specialists. It facilitates the administration of medications, fluids, and the monitoring of central venous pressure.
FDA Clearance Information
Pathway
510K
Number
K002507 ↗
Decision Date
March 21, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on March 21, 2001, by Arrow Intl. It is classified as a Class 2 medical device under product code DYB.
What It Is
The two-lumen central venous access kit is a medical device designed for the insertion of a central venous catheter. It features a hemostasis valve side port to minimize blood loss during catheter insertion. This device allows for the simultaneous administration of medications and fluids, as well as the measurement of central venous pressure, which is crucial in managing critically ill patients.
Clinical Applications
This device is commonly used in intensive care units, operating rooms, and emergency departments. It is essential for patients requiring long-term intravenous therapy, hemodynamic monitoring, or rapid fluid resuscitation. Specialties that frequently use this device include anesthesiology, critical care, and emergency medicine, particularly for patients with complex medical needs.
Indications for Use
The device is indicated for patients who need central venous access for medication administration, fluid management, or hemodynamic monitoring. It is suitable for use in patients with conditions requiring precise fluid and medication management, such as sepsis or major surgery.
Practical Considerations
Clinicians should be familiar with the typical catheter sizes and ensure compatibility with other medical devices. The hemostasis valve side port is designed to reduce blood loss and air embolism risk during insertion. Proper aseptic technique is crucial to prevent infection.
Frequently Asked Questions
What is the two-lumen central venous access kit used for?
It is used for central venous catheterization to administer medications, fluids, and monitor central venous pressure.
What specialties typically use this device?
Anesthesiology, critical care, and emergency medicine specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for central venous access in patients needing medication administration, fluid management, or hemodynamic monitoring.
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.