| Device |
securement wound dressing for reduction of infection |
| Definition |
These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI). |
| Physical State |
A solid wound dressing that contains chlorhexidine gluconate and has an adhesive backing. |
| Technical Method |
A solid wound dressing that contains chlorhexidine gluconate and has an adhesive backing. |
| Target Area |
Over a vascular or percutaneous device |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | SEL |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
|
Unclassified Reason
|
Pre-Amendment
|
|---|
| Submission Type |
510(k)
|
|---|
| Device Class |
Unclassified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
