ClearGuard HD Antimicrobial Barrier Cap

GUDID B081CGHD102247173

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.

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Primary Device IDB081CGHD102247173
NIH Device Record Keyd5a5a317-5fdc-4a19-ac69-30d109012968
Commercial Distribution Discontinuation2024-02-15
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearGuard HD Antimicrobial Barrier Cap
Version Model NumberCGHD
Company DUNS962595125
Company NamePursuit Vascular, Inc.
Device Count1
DM Exempttrue
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
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
Phone949-366-2183
Emailcustomerservice@icumed.com
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
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]
HIBCCB081CGHD102247173 [Primary]

FDA Product Code

PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
PEHHemodialysis Catheter Luer End Cap
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 Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [ClearGuard HD Antimicrobial Barrier Cap]

B081CGHD111236945ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236959ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236960ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236961ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236962ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236963ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236964ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111236965ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112236965ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112236967ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112236968ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112236969ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237031ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237032ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237033ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237034ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237035ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237036ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237037ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237038ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237039ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237040ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237041ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237042ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237043ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237044ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237045ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237046ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112237047ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247163ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247164ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247165ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247166ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247167ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247168ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247169ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247170ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247171ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247172ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247173ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247175ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247174ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247176ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247177ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247178ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247179ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247180ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD102247181ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end

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