AccessGUDID - DEVICE: ClearGuard HD (B081CGHD111193766)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B081CGHD111193766
Issuing Agency: HIBCC
Commercial Distribution End Date: November 09, 2019
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?
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Active	true

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: 0f5d51a0-6612-48d6-9ad5-d357b950c6e0
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: January 10, 2017