AccessGUDID - DEVICE: ClearGuard HD Antimicrobial Barrier Cap (B081CGHD106247252)

GUDID

Device Identifier (DI) Information

Brand Name: ClearGuard HD Antimicrobial Barrier Cap
Version or Model: CGHD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Pursuit Vascular, Inc.

Primary DI Number: B081CGHD106247252
Issuing Agency: HIBCC
Commercial Distribution End Date: June 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962595125 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61141	Luer-formatted disinfection cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a connector in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEH	Hemodialysis Catheter Luer End Cap

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0a58e2c-2406-4680-80c2-8e70f3cf5a4d
Public Version Date: June 03, 2024
Public Version Number: 2
DI Record Publish Date: June 03, 2021