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mac two-lumen central venous kit with arrowg ard blue antimicrobial surface and integral hemostasis valve side port
Arrow Intl.
Summary: The mac two-lumen central venous kit with Arrowg+ard Blue is used for central venous access, providing antimicrobial protection. It is typically used by anesthesiologists and critical care specialists.
FDA Clearance Information
Pathway 510K
Number K011761 ↗
Decision Date October 31, 2001
Product Code DYB
Device Class Class 2
Evidence 0 studies
The mac two-lumen central venous kit was cleared through the FDA 510(k) pathway on October 31, 2001. Manufactured by Arrow Intl., it is a Class 2 medical device.
What It Is
This device is a central venous catheter kit designed for vascular access. It features two lumens, allowing for simultaneous infusion of medications and fluids. The Arrowg+ard Blue antimicrobial surface helps reduce infection risk, and the integral hemostasis valve side port aids in maintaining hemostasis during use.
Clinical Applications
Commonly used in critical care and surgical settings, this device is essential for procedures requiring central venous access, such as fluid resuscitation, medication administration, and central venous pressure monitoring. It is used in adult and pediatric patients, particularly in intensive care units and operating rooms.
Indications for Use
The device is indicated for patients requiring central venous access, such as those needing long-term medication administration, fluid management, or hemodynamic monitoring. It is suitable for patients in critical care or undergoing major surgery.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with standard central line insertion techniques and can be used with ultrasound guidance for improved accuracy and safety.
Frequently Asked Questions
What is the mac two-lumen central venous kit used for?
It is used for central venous access to administer medications, fluids, and for hemodynamic monitoring.
What specialties typically use this device?
Anesthesiology, critical care, and emergency medicine specialists commonly use this device.
What are the FDA-cleared indications?
It is cleared for use in patients requiring central venous access for medication delivery, fluid management, and 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.