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510(k) Data Aggregation
K Number
K103106Device Name
CHLORASHIELD TM ANTIMICROBIAL DRESSING
Manufacturer
Date Cleared
2011-03-30
(161 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CARE FUSION 213 LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ChloraShield™ Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices.
Device Description
The ChloraShield™ Antimicrobial Dressing is intended to fill the need for a transparent primary catheter dressing that can be applied easily while surrounding the wound site. The dressing is an oval shaped dressing intended to cover and protect a catheter site and absorb exudates. The dressing is transparent and conformable allowing for easy visual and manual inspection of IV sites. The dressing is impregnated with Chlorhexidine Gluconate (CHG), a persistent, broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms. The antimicrobial agent protects the dressing from bacterial penetration and colonization. The patch complements other infection control measures by providing continued IV site protection while also allowing for good site visualization and inspection. ChloraShield has not been clinically tested for its ability to reduce local infections, catheter-related blood stream infections (CRBSI) or skin colonization of microorganisms commonly related to CRBSI. The product is sold in a sterile condition, opened in the operating field and then applied to the catheter site. Like the predicate devices, the ChloraShield ™ Dressing is easy to apply and easy to remove. The product offering includes: The product number is: # 410100 standard package - one dressing or patch per sterile package.
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