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510(k) Data Aggregation
K Number
K043063Device Name
OXYBAND WOUND DRESSING
Manufacturer
OXYBAND TECHNOLOGIES, INC.
Date Cleared
2005-03-24
(139 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
OXYBAND TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OxyBand ™ Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other would products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage For II pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
The Over-The-Counter OxyBand ™ Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor burns, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.
Device Description
OxyBand™ is a multilayer wound dressing that keeps out water, dirt and germs, and supplies oxygen to the wound. It is designed to be applied directly over clean skin or wounds for up to 5 days. A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter.
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