SEL

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Securement Wound Dressing For Reduction Of Infection

Device class

Unclassified

Medical specialty

Unknown

FDA 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).

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