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510(k) Data Aggregation
K Number
K223914Device Name
ACTIV Cap
Manufacturer
Cleansite Medical, Inc.
Date Cleared
2024-04-05
(463 days)
Product Code
QBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.
Device Description
The Subject Device is a sterile, single-use device that is used to clean and disinfect needleless vascular access ports and then act as a cover for the access port between uses. Covering between uses maintains the port's cleanliness. The Subject Device is made of a plastic inner threaded housing snapped into an outer cap and incorporates a foam substrate that protrudes into the central bore of the inner housing and is moistened with the active disinfectant, 70% Isopropyl Alcohol (IPA). The IPA-filled cap is sealed with a poly/foil film to prevent excessive loss of the active ingredient and maintain the sterile barrier.
The Subject Device reduces the risk of unintentional removal by requiring a slight compression force (i.e., pinching) on the cap's side to remove, which force causes the outer housing to engage the inner housing so as to allow the inner and outer housings to be rotated in unison in order to attach and remove the Subject Device from a threaded needleless vascular access port. Without compression, once secured to a needleless vascular access port the Subject Device's outer housing can be rotated in relation to the inner housing and needleless vascular access port to further clean the surface of the access port.
Once the Subject Device is installed on a needless vascular access port, the device passively disinfects the contacting surfaces with the 70% IPA moistened foam.
Ten (10) sealed devices are assembled onto a card hanger that can be hung in an IV pole. Twenty (20) assembled cards are packaged into an inner carton. The instructions for use are printed on the outside on the inner carton. Twenty-four (24) inner cartons are packaged into a corrugated shipper. The packaging shipper is sterilized by gamma irradiation to a Sterility Assurance Level (SAL) of 10-6.
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K Number
K193190Device Name
BD PureHub Disinfecting Cap
Manufacturer
Becton, Dickinson and Company
Date Cleared
2020-11-09
(356 days)
Product Code
QBP, OBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.
BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.
Device Description
BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip.
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K Number
K200299Device Name
Curos Jet Disinfecting Cap
Manufacturer
3M Company
Date Cleared
2020-10-29
(266 days)
Product Code
QBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to I.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
Device Description
The 3M™ Curos Jet™ Disinfecting Cap is a single use, sterile cap that contains 70% Isopropy Alcohol and is intended to disinfect and protect needleless connectors. The Curos Jet™ Disinfecting Cap is translucent green in color. The device consists of a molded high-density polyethylene (HDPE) cap designed to fit onto female threads of a needleless connector, containing a HDPE plunger within. This plunger, when the cap is screwed onto a connector, travels towards a reservoir of 70% Isopropyl Alcohol, releasing it onto the needleless connector for disinfection. The Curos Jet™ Disinfecting Cap is offered in one size only, however it is packaged in "single" (1-cap) and "strip" (5-cap) configurations on a foil seal.
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K Number
K192382Device Name
CapKlenZ
Manufacturer
Star Mountain Medical, Inc.
Date Cleared
2020-04-20
(234 days)
Product Code
QBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When left in place for 3 minutes, the CapKlenZ disinfects needleless luer access valves; thereafter the CapKlenZ provide a physical barrier to contamination up to 168 hours under normal conditions if not removed.
Device Description
CapKlenZ consists of a solid reservoir made of polyethylene, which contains an absorbent material and 70% isopropyl alcohol (70% IPA).
The opening of the reservoir is mechanically attached to a threaded membrane made of non-DEHP, non-latex elastomer, which lays in the internal geometry of the reservoir, this membrane is intended to be threaded to a needleless port connector and adapt to its shape. The reservoir and its contents are sealed with an extrusion laminated composite of polyester, polyethylene, aluminum foil, and a peelable sealant, which has to be removed before use.
Once the needleless port connector is threaded, the shape and elasticity of the threaded membrane, isolates the proximal end of the needleless port connector within the interior of the reservoir along with the absorbent material and 70% IPA. When the needleless port connector is threaded into the membrane, the circular movement of the connector scrubs its tip against the absorbent material and exposes it to 70% IPA in order to disinfect it.
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K Number
K190918Device Name
SwabTip Male Disinfectant Cap
Manufacturer
ICU Medical
Date Cleared
2020-03-06
(332 days)
Product Code
QBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SwabTip™ is intended for use on ISO male luer connectors as a cover to protect the luer from potential contamination. The SwabTip™ acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabTip™ will disinfect the male luer (30) seconds after application and maintains a disinfected luer surface for up to four days (96 hours) if not removed.
Device Description
SwabTip™ Male Disinfectant Cap is an accessory to the terminal male luer of an intravenous administration set that is used to disinfect and maintain a physical barrier when the administration set is not in use. The SwabTip™ is a cap that when attached to an ISO compatible male luer slip, lock, or spin luer, delivers a small volume of 70% isopropyl alcohol to the external surfaces of the male luer including the internal threads. SwabTip™ is a single use sterile fluid path cap, provided in multi-unit delivery strip.
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K Number
K142806Device Name
DualCap
Manufacturer
CATHETER CONNECTIONS, INC.
Date Cleared
2015-05-22
(235 days)
Product Code
QBP, LKB
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When left in place for 30 seconds the Light Blue DualCap® disinfects needleless luer access valves and the Dark Blue DualCap® disinfects the IV administration line male luer connections; the caps provide a physical barrier to contamination up to 7 days, under normal conditions if not removed.
Device Description
The DualCap® Disinfectant Cap is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The Subject device is not made with natural rubber latex, is non-pyrogenic, non-preservative and is not made with DEHP. The product consists of a Light Blue DualCap® for use on Luer access valves and a Dark Blue DualCap® for use on IV administration line male Luer connections. The Light Blue DualCaps® and Dark Blue DualCaps® are available in a number of packaging combinations such as two Light Blue DualCaps®, a Light Blue DualCap® and Dark Blue DualCap® combination, and as singles.
Additionally, DualCap® Disinfectant Caps will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk to the kitting manufacturer.
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K Number
K140657Device Name
CUROS RED PORT PROTECTOR
Manufacturer
IVERA MEDICAL, INC.
Date Cleared
2014-12-04
(265 days)
Product Code
QBP, LKB
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Curos Red is intended for use on dialysis catheter female Luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. In three (3) minutes after application, the Curos Red will disinfect the female Luer and act as a cover until removed. The Ivera Curos Red was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans. The Curos Red in the home or healthcare facility.
Device Description
The Curos Red Port Protector contains 70% Isopropyl alcohol and is intended for use on dialysis catheter open female luers and open female ports on stopcocks as a disinfecting cleaner prior to line connection and to act as a cover between line accesses. The Curos Red has a highly visible red color that may allow improved compliance monitoring by easy visual verification to ensure that all open female luers are disinfected and covered. The Curos Red may be used in the home or healthcare facility.
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K Number
K142399Device Name
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
Manufacturer
CATHETER CONNECTIONS, INC.
Date Cleared
2014-11-19
(84 days)
Product Code
QBP, IFB, LKB, OBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When left in place for five (5) minutes, the Dark Blue DualCap disinfects male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Device Description
The Dark Blue DualCap" is designed to Internet on all ISO standard mater and man and newides effective disintection of the male luer fromector after five minutes of applicat sterite. This device is not made with natural rubber latex, is non-pyrogenic, preservative free and is not made with DEHP, Additionally Datk Blue DualCap® will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterite to the kitting manufacturer for incorporation into the procedure Kits,
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K Number
K130975Device Name
SWABCAP AND SWABFLUSH
Manufacturer
EXCELSIOR MEDICAL CORP.
Date Cleared
2013-12-24
(260 days)
Product Code
QBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.
Device Description
SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.
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K Number
K123967Device Name
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
Manufacturer
CATHETER CONNECTIONS, INC.
Date Cleared
2013-01-22
(27 days)
Product Code
QBP, OBP
Regulation Number
880.5440Why did this record match?
Product Code :
QBP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When left in place for five (5) minutes, the dark blue DualCap™ for male luer connectors disinfects the IV administration line male luer connectors; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Device Description
The dark blue DualCap™ for male luers is designed to fit securely on IV administration male luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile. This device is not made with natural rubber latex, non-pyrogenic, preservative free and DEHP free.
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