BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ClearGuard HD

    DI: B081CGHD109215276 · Model: CGHD · Pursuit Vascular, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ClearGuard HD
    Primary DI
    B081CGHD109215276
    Version / Model
    CGHD
    Company Name
    Pursuit Vascular, Inc.
    Labeler DUNS
    962595125
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-11
    Public Version
    3
    Public Version Date
    2021-09-13
    Public Version Status
    Update
    Public Device Record Key
    ef15dd43-b7f7-4b01-a35d-3e341c371ea6
    Distribution End Date
    2021-09-11

    Device Description

    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.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PEH Hemodialysis Catheter Luer End Cap

    GMDN Terms

    Code Name
    37278 Double-lumen haemodialysis catheter, implantable

    Identifiers

    Type ID
    Primary B081CGHD109215276