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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a transparent protective dressing over catheter insertion sites.
- Use as a transparent protective dressing over wounds.
Clinical Applications
- Covering and protecting central venous catheter insertion sites.
- Covering and protecting peripheral intravenous catheter sites.
- Covering minor wounds when a transparent protective barrier is appropriate.
- Allowing visual inspection of the catheter site or wound without removing the dressing.
Practical Considerations
- Choose a dressing size that fully covers the catheter insertion site or wound with an adequate margin of intact skin.
- Apply the dressing to clean, dry skin using aseptic technique; moisture, oils, blood or drainage can reduce adhesion.
- Inspect the site regularly for redness, drainage, swelling, pain, fever or dressing disruption, and replace it according to institutional protocol or if it becomes loose, wet or contaminated.
- The record does not provide product-specific MRI-safety information. Confirm the current labeling and institutional MRI policy before use in an MRI environment.
- Do not use on patients with a known sensitivity to the dressing or its adhesive components, and follow product labeling for use on damaged or infected skin.
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.