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510(k) Data Aggregation
K Number
K132004Device Name
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
Manufacturer
CREO QUALITY, LLC.
Date Cleared
2014-05-02
(305 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
CREO QUALITY, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.
When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.
Device Description
Cork Medical Products NPWT Wound Dressing Kit is comprised of components necessary to dress a wound for negative pressure wound therapy. The kit includes reticulated, 30 pores per inch (PPI), polyether, polyurethane foam; transparent polyurethane film drape with adhesive backing; and port pad assembly comprised of silicone port pad, drainage tubing, luer connector, pinch clamp, and transparent polyurethane film drape with adhesive backing.
The kits are available in two (2) sizes: medium and large based on the size of the foam. The medium foam is: 0.75″ x 5″ x 8″. The large foam is 0.75″ x 6″ x 10″. Each kit is single-use and housed in a Tyvek peel pouch, which is sterilized using ethylene oxide.
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