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510(k) Data Aggregation
K Number
K121485Device Name
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
Manufacturer
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD
Date Cleared
2012-08-21
(95 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemCon GuardIVa® Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.
Device Description
The HemCon® GuardIVa® Antimicrobial Hemostatic IV Dressing is a sterile hydrophilic, absorptive polyurethane sponge dressing impregnated with the broad spectrum antimicrobial agent chlorhexidine gluconate (CHG) and HemCon's proprietary hemostatic agent, microdispersed oxidized cellulose (m.doc™). The dressing is backed with a non-stick polyurethane film and is individually packaged in a peelable low density polyethylene (LDPE) and Tyvek® pouch. The dressing is provided both sterile. The sterile version of the dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-°. The hemostatic properties of m.doc™ enhances the ability of the foam to control surface bleeding from percutaneous catheters and vascular access sites. CHG is a well known antiseptic agent with broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms yeast and fungi. The CHG antimicrobial agent protects the dressing from microbial colonization. GuardIVa® is an adjunct to infection control measures by providing sustained IV site protection, GuardIVa® has not been clinically tested for its ability to reduce catheter related blood stream infections (CR-BSI).
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K Number
K093729Device Name
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
Manufacturer
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD
Date Cleared
2010-06-08
(187 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing is intended for use as a hydrophilic wound dressing to absorb exudate, cover and protect catheter sites. Common applications include IV catheters, other intravenous catheters and percutaneous devices. It is also indicated for control of surface bleeding from percutaneous catheters and vascular access sites.
Device Description
The HemCon GuardIVa™ Antimicrobial Hemostatic IV Dressing is a sterile hydrophilic polyurethane absorptive foam impregnated with chlorhexidine gluconate (CHG) and microdispersed oxidized cellulose (m.doc™) and backed with a non-stick polyethylene film. This one inch diameter dressing is packaged in a peelable low density polyethylene (LDPE) and Tyvek® pouch. The dressing will be provided both sterile and non-sterile. The sterile pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The haemostatic properties of m.doc™ provides the dressing with the ability to control surface bleeding from percutaneous catheters and vascular access sites. Chlorhexidine gluconate acts as a preservative to inhibit the growth of microorganisms within the dressing. CHG is a well known antiseptic agent with broad spectrum antimicrobial and antifungal activity against a wide range of gram positive and gram negative organisms, including methicillin resistant Staphylococcus aureus ATCC33591 (MRSA), vancomycin-resistant Enterococcus faecalis ATCC51299 (VRE) and Acinetobacter baumanii ATCC15308. GuardIVa™ has not been clinically tested for its ability to reduce local infections, catheter related blood stream infections (CR-BSI) and skin colonization of microorganisms commonly related to CR-BSI.
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