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510(k) Data Aggregation
K Number
K132380Device Name
PREVANTICS DEVICE SWAB
Manufacturer
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Date Cleared
2014-08-27
(392 days)
Product Code
LKB
Regulation Number
N/AWhy did this record match?
Product Code :
LKB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use.
Device Description
The Prevantics® Device swab is available as a 2 in. x 2 in. swab which contains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol). The product is intended for single, non-sterile use and is not made with natural rubber latex. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devises.
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K Number
K121655Device Name
BD ALCOHOL SWAB
Manufacturer
BECTON DICKINSON & CO.
Date Cleared
2013-03-20
(288 days)
Product Code
LKB
Regulation Number
N/AWhy did this record match?
Product Code :
LKB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab disinfects needleless access sites prior to use. It may be used in the home or healthcare facility.
Device Description
The BD Alcohol Swab is a single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol and intended to for needleless access site disinfection.
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K Number
K112791Device Name
SITESCRUB IPA DEVICE
Manufacturer
CR BARD
Date Cleared
2012-02-24
(151 days)
Product Code
LKB
Regulation Number
N/AWhy did this record match?
Product Code :
LKB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.
Device Description
The subject Site-Scrub IPA Device is a handheld, sterile, single use device containing isopropyl alcohol (IPA) 70% (v/v) solution. The Site-Scrub IPA Device, by design, provides active mechanical friction and IPA to clean and disinfect surfaces, such as injection ports and female luer hubs, in accordance with 2011 CDC guidelines that recommend for needleless intravascular catheter systems that contamination be minimized by "scrubbing the access port with an appropriate antiseptic (including 70% alcohol) and accessing the port only with sterile devices." The foam design allows for application of the IPA on internal and external surfaces. The Site-Scrub IPA Device has been specifically designed to disinfect female luer hubs and injection ports and has undergone in vitro testing to validate its effectiveness for this purpose. The results of in vitro antimicrobial efficacy testing show the Site-Scrub IPA Device is effective, when used as intended, for significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of the following microbes known to be associated with catheter line-associated blood stream infections (CLABSI) which include: 1. Candida albicans, 2. Candida parapsilosis, 3. Escherichia coli, 4. Pseudomonas aeruginosa, 5. Staphylococcus aureus (MRSA), and 6. Staphylococcus epidermidis (MRSE).
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