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ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215303 ()
- Double-lumen haemodialysis catheter, implantable
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215287 ()
- Double-lumen haemodialysis catheter, implantable
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215286 ()
- Double-lumen haemodialysis catheter, implantable
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215285 ()
- Double-lumen haemodialysis catheter, implantable
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215284 ()
- Double-lumen haemodialysis catheter, implantable
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours.
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215283 ()
- Double-lumen haemodialysis catheter, implantable
The ClearGuard HD Antimicrobial Barrier Cap is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces. The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215278 ()
- Double-lumen haemodialysis catheter, implantable
The ClearGuard HD Antimicrobial Barrier Cap is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces. The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215277 ()
- Double-lumen haemodialysis catheter, implantable
The ClearGuard HD Antimicrobial Barrier Cap is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces. The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215276 ()
- Double-lumen haemodialysis catheter, implantable
The ClearGuard HD Antimicrobial Barrier Cap is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces. The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.
The ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution
- B081CGHD109215275 ()
- Double-lumen haemodialysis catheter, implantable