ClearGuard HD Antimicrobial Barrier Cap

GUDID B081CGHD111236945

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.

Luer-formatted disinfection cap Luer-formatted disinfection cap Luer-formatted disinfection cap Luer-formatted disinfection cap
Primary Device IDB081CGHD111236945
NIH Device Record Keyb5634852-87e1-44c4-9c9a-828eb275d3bd
Commercial Distribution Discontinuation2023-11-02
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearGuard HD Antimicrobial Barrier Cap
Version Model NumberCGHD
Company DUNS962595125
Company NamePursuit Vascular, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB081CGHD111236945 [Primary]
HIBCCB081CGHD111236945 [Primary]
HIBCCB081CGHD111236945 [Primary]
HIBCCB081CGHD111236945 [Primary]

FDA Product Code

PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by Pursuit Vascular, Inc.

B081CGHD111236945 - ClearGuard HD Antimicrobial Barrier Cap2020-11-10ClearGuard 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.
B081CGHD111236945 - ClearGuard HD Antimicrobial Barrier Cap2020-11-10 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236872 - ClearGuard HD2020-11-09 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236871 - ClearGuard HD2020-11-06 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236870 - ClearGuard HD2020-11-05 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236869 - ClearGuard HD2020-11-04 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236868 - ClearGuard HD2020-11-03 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236867 - ClearGuard HD2020-11-02 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap
B081CGHD110236866 - ClearGuard HD2020-10-30 ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap

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