Securement Wound Dressing For Reduction Of Infection
SEL · Unclassified · Unknown
Classification
FDA Product Code
SEL
Device class
Unclassified
Regulation
—
Review panel
SU
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).