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510(k) Data Aggregation
K Number
K080471Device Name
RADIO BIOAQUACARE
Manufacturer
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
Date Cleared
2008-03-05
(13 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.
Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.
Device Description
Radio BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG.Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in Radio BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. Radio BioAquaCare™ contains up to 85% water which enables the dressing to provide a moist environment even if the wound bed is dry. Radio BioAquaCare™ will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed. Radio BioAquaCare™ does not include any medicinal substance, animal/human tissue, or biologics. Radio BioAquaCare™ is supplied with gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
Radio BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. Radio BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 8 cm x 10 cm, 8 cm x 20 cm, 8 cm x 27 cm, 8 cm x 30 cm, 8 cm x 40 cm, 8 cm x 50 cm, 10 cm x 10 cm, 10 cm x 20 cm, 10 cm x 27 cm, 10 cm x 30 cm, 10 cm x 40 cm, 10 cm x 50 cm, 15 cm x 10 cm, 15 cm x 20 cm, 15 cm x 30 cm, 15 cm x 40 cm, or 15 cm x 50 cm). Radio BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 lean room environment.
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K Number
K072068Device Name
BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS
Manufacturer
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
Date Cleared
2007-12-21
(147 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.
BioAquaCare™ is intended for single use only.
BioAquaCare™ is not intended for treatment of third degree burns.
Device Description
BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.
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