Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K032734
    Device Name
    CONVATEC FECAL MANAGEMENT SYSTEM
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO.
    Date Cleared
    2004-04-08

    (217 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why 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
    Ask a Question
    K Number
    K990368
    Device 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/A
    Why 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.
    Ask a Question
    K Number
    K982116
    Device Name
    AQUACEL HYDROFIBER WOUND DRESSING
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO.
    Date Cleared
    1998-09-08

    (84 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why 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.
    Ask a Question
    K Number
    K973806
    Device 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/A
    Why 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.
    Ask a Question
    K Number
    K973807
    Device 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/A
    Why 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.
    Ask a Question
    K Number
    K973716
    Device 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/A
    Why 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.
    Ask a Question
    K Number
    K973717
    Device Name
    COMBIDERM ACD
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO.
    Date Cleared
    1997-12-17

    (79 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why 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.
    Ask a Question

    Page 1 of 1