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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).

Market data

Cleared 510(k) submissions
3
Registered establishments
13

Source

Authoritative
FDA Device Classification database
Machine
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