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510(k) Data Aggregation
K Number
K083133Device Name
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS
Manufacturer
ANDOVER HEALTHCARE INC.
Date Cleared
2009-10-30
(372 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ANDOVER HEALTHCARE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a health care professional, CoFlex -X AFD® and the CoFlex -X AFD® Pad contact wound dressings are indicated for use in light to heavy exuding partial and full thickness wounds, including decubitus and diabetic ulcers, 1st and 2nd degree burns, and donor sites. These dressings may also be used over debrided and partial thickness wounds.
For over the-counter use, PowerFlex NL - X AFD® and CoFlex - X AFD® First Aid contact wound dressings are indicated for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Device Description
The Andover Healthcare, Inc. X AFD Dressings are offered in four configurations for both over the counter use or prescription use. The dressings are described below:
CoFlex - X AFD® foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and non-adherent. CoFlex - X AFD® dressings are designed to intimately contact the wound as a primary barrier dressing. This barrier, in combination with the X-STATIC® silver (1.5%), as determined by barrier strike through testing, prevents the penetration of microbes through the outer surface and into the dressing.
CoFlex - X AFD® First Aid foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and nonadherent. CoFlex - X AFD® First Aid dressings are designed to intimately contact the wound as a primary dressing.
CoFlex - X AFD® Pad foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic backing which will readily adhere to a latex-free cohesive elastic bandage wrap, rapidly facilitating the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and non-adherent. CoFlex - X AFD® Pad dressings are designed to intimately contact the wound as a primary barrier dressing. This barrier, in combination with the X-STATIC® silver (1.5%), as determined by barrier strike through testing, prevents the penetration of microbes through the outer surface and into the dressing.
PowerFlex NL - X AFD® foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and nonadherent. PowerFlex NL - X AFD® dressings are designed to intimately contact the wound as a primary dressing.
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