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510(k) Data Aggregation
K Number
K023456Device Name
OXYBOX SYSTEM
Manufacturer
Date Cleared
2003-02-24
(132 days)
Product Code
Regulation Number
878.5650Why did this record match?
Applicant Name (Manufacturer) :
OXYFAST CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
Device Description
OxyBox is a topical bandage system that incorporates a disposable oxygen concentrator. It consists of three separate component parts: (1) the oxygen concentrator, (2) the sterile cannula and (3) the bandage or wound dressing. Items (2) and (3) are medical grade commercial products that Oxyfast Corporation obtains from device manufacturers or distributors. The oxygen concentrator is a single patient, one time use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
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