ClearGuard HD
- Primary DI
- B081CGHD105225732
- Brand
- ClearGuard HD
- Company
- Pursuit Vascular, Inc.
- Model
- CGHD
- 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.
- Published
- 2019-05-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| PEH | Hemodialysis Catheter Luer End Cap |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PEH | Hemodialysis Catheter Luer End Cap | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B081CGHD105225732 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Vascular catheter disinfection cap | A sterile (or with sterile fluid path) cap intended to be placed on one of the alternative connectors 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. |
Regulatory Flags
- DUNS number
- 962595125
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10887709123592 | ICU Medical | ICU MEDICAL, INC. | PEH | 2024-01-18 |
| B081CGHD109258247 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-30 |
| B081CGHD109258246 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-29 |
| B081CGHD109258245 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-28 |
| B081CGHD109258244 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-27 |
| B081CGHD109258243 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-26 |
| B081CGHD109258242 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-23 |
| B081CGHD109258241 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-22 |
| B081CGHD109258240 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-21 |
| B081CGHD109258239 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-20 |
| B081CGHD109258238 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-19 |
| B081CGHD109258237 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-16 |
| B081CGHD109258236 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-15 |
| B081CGHD109258235 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-14 |
| B081CGHD109258234 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-13 |
| B081CGHD109258233 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-12 |
| B081CGHD1089258232 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-09 |
| B081CGHD109258231 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-08 |
| B081CGHD109258230 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-07 |
| B081CGHD109258229 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-06 |
| B081CGHD109258228 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-05 |
| B081CGHD109258227 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-02 |
| B081CGHD109258226 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-09-01 |
| B081CGHD108258225 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-31 |
| B081CGHD108258224 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-30 |
| B081CGHD108258223 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-29 |
| B081CGHD108258222 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-26 |
| B081CGHD108258221 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-25 |
| B081CGHD108258220 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-24 |
| B081CGHD108258219 | ClearGuard HD | Pursuit Vascular, Inc. | PEH | 2022-08-23 |