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Found 7 results
510(k) Data Aggregation
K Number
K032734Device Name
CONVATEC FECAL MANAGEMENT SYSTEM
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
2004-04-08
(217 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid
Device Description
ConvaTec Fecal Management System
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K Number
K990368Device Name
DUODERM HYDROACTIVE GEL WOUND DRESSING
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1999-03-26
(46 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-The Counter Use, DuoDERM Hydroactive Gel Wound Dressing may be used for abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a healthcare professional, DuoDERM Hydroactive Gel may be used for the hydration and management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers and skin conditions resulting from radiation dermatitis.
Device Description
DuoDERM Hydroactive Gel Wound Dressing is substantially equivalent to Carrasyn Hydrogel Wound Dressing. The products are equivalent in intended use and function. Both products provide a moist wound healing environment. DuoDERM Hydroactive Gel Wound Dressing is also capable of absorbing exudate.
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K Number
K982116Device Name
AQUACEL HYDROFIBER WOUND DRESSING
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1998-09-08
(84 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.
Device Description
Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing.
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K Number
K973806Device Name
DUODERM HYDROACTIVE GEL
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-29
(84 days)
Product Code
MGQ, MGO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.
Device Description
The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration.
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K Number
K973807Device Name
DUODERM HYDROACTIVE PASTE
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-23
(78 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DuoDERM Hydroactive Paste is designed to be used with a secondary dressing such as DuoDERM Dressings for the local management of exudating dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.
Device Description
The concept of DuoDERM Hydroactive Paste is not significantly different from other commercially available absorbent dressings intended for use in the management of exudating wounds. DuoDERM Hydroactive Paste is indicated for use on exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers and diabetic ulcers. It is used in association with other DuoDERM® dressings.
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K Number
K973716Device Name
DUODERM EXTRA THIN CGF DRESSING
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-17
(79 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DuoDERM Extra Thin CGF Dressings is indicated for use on chronic wounds-dry to lightly exuding dermal ulcers, including diabetic ulcers; acute wounds (e.g., post operative wounds); and as a protective dressing for areas at risk for skin breakdown. DuoDERM Extra Thin CGF Dressing provides a moist wound environment that is necessary for the healing process.
Device Description
The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds.
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K Number
K973717Device Name
COMBIDERM ACD
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-17
(79 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers including full-thickness wounds, such as pressure ulcers, leg ulcers and diabetic ulcers, and on acute wounds such as abrasions, lacerations, biopsies, and oven and closed surgical wounds. The dressing provides a moist wound environment that is supportive of the healing process.
Device Description
CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers, including full thickness wounds such as pressure ulcers and diabetic ulcers and for acute wounds, such as abrasions, lacerations, biopsies, and open and closed surgical wounds. CombiDERM ACD wicks exudate away from the wound and provides a moist wound environment that is supportive of the healing process. The moist environment aids autolytic debridement and allows non-traumatic removal of the dressing without damaging newly formed tissue.
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