đź“‹ FDA Reference
centurion r site guard r transparent dressing transpaent film dressing
Tri-State Hospital Supply
Summary: The Centurion R Site Guard R is a transparent film dressing used primarily to protect catheter sites and wounds. It is commonly used by healthcare professionals in various clinical settings to maintain a sterile environment.
FDA Clearance Information
Pathway
510K
Number
K945977 ↗
Decision Date
March 29, 1995
Product Code
MGP
Device Class
—
Evidence
0 studies
The Centurion R Site Guard R was cleared by the FDA via the 510k pathway on March 29, 1995. It is manufactured by Tri-State Hospital Supply and does not have a specific device classification.
What It Is
The Centurion R Site Guard R is a transparent film dressing designed to cover and protect catheter sites and wounds. It acts as a barrier against contaminants while allowing visibility of the site for monitoring. The dressing is breathable, promoting moisture vapor exchange while maintaining a sterile environment.
Clinical Applications
This dressing is commonly used in hospitals and outpatient settings, particularly in departments such as oncology, surgery, and intensive care. It is ideal for protecting central venous catheter sites, peripheral IV sites, and minor wounds. The dressing is suitable for a wide range of patient populations, including those requiring long-term catheterization or wound care.
Indications for Use
The FDA indications suggest that this dressing is used to protect catheter sites and wounds from infection and contamination. It is intended for patients who require a sterile barrier over their catheter insertion points or wounds.
Practical Considerations
The Centurion R Site Guard R is available in various sizes to accommodate different catheter sites and wound sizes. It is important to ensure proper application technique to maintain its protective barrier. The dressing is compatible with most skin types and is designed for easy application and removal.
Frequently Asked Questions
What is Centurion R Site Guard R used for?
It is used to protect catheter sites and wounds from infection and contamination while allowing visibility for monitoring.
What specialties typically use this device?
Specialties such as oncology, surgery, and intensive care commonly use this device.
What are the FDA-cleared indications?
The device is indicated for protecting catheter sites and wounds from infection and contamination.
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.