ClearGuard HD

GUDID B081CGHD110236872

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 Luer-formatted disinfection cap Luer-formatted disinfection cap Luer-formatted disinfection cap Luer-formatted disinfection cap
Primary Device IDB081CGHD110236872
NIH Device Record Keydf722553-6de4-407f-88f3-957c9dd15d87
Commercial Distribution Discontinuation2023-10-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearGuard HD
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [Primary]
HIBCCB081CGHD110236872 [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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [ClearGuard HD]

B081CGHD103225593ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD103225594ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD103225615ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD103225616ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215436ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215435ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215427ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215426ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215425ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215424ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215421ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215420ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215419ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215418ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215413ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215412ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215411ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112215410ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204286ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204285ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204284ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204283ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204280ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204279ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204278ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204277ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204274ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204273ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204272ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112204271ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193820ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193819ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193818ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193813ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193812ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193811ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193810ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193808ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193807ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193806ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193804ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193803ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193802ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD112193789ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215409ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215408ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215407ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215379ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215378ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
B081CGHD111215377ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end

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