ClearGuard HD

GUDID B081CGHD112193803

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.

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: B081CGHD112193803
• NIH Device Record Key: 8f64bae4-fffd-4373-9e4b-400d24939047
• Commercial Distribution Discontinuation: 2019-12-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ClearGuard HD
• Version Model Number: CGHD
• Company DUNS: 962595125
• Company Name: Pursuit Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B081CGHD112193803 [Primary]

FDA Product Code

• PEH: Hemodialysis Catheter Luer End Cap

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-06
• Device Publish Date: 2016-12-12

On-Brand Devices [ClearGuard HD]

• B081CGHD103225593: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD103225594: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD103225615: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD103225616: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215436: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215435: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215427: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215426: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215425: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215424: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215421: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215420: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215419: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215418: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215413: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215412: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215411: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112215410: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204286: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204285: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204284: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204283: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204280: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204279: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204278: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204277: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204274: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204273: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204272: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112204271: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193820: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193819: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193818: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193813: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193812: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193811: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193810: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193808: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193807: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193806: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193804: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193803: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193802: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD112193789: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215409: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215408: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215407: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215379: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215378: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end
• B081CGHD111215377: ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end