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510(k) Data Aggregation

    K Number
    K004028
    Device Name
    ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
    Manufacturer
    MAERSK MEDICAL, LTD.
    Date Cleared
    2001-03-27

    (90 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAERSK MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990810
    Device Name
    ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
    Manufacturer
    MAERSK MEDICAL, LTD.
    Date Cleared
    1999-09-17

    (190 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAERSK MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FILM DRESSING ARGLAES-AB Antimicrobial Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters. ISLAND DRESSING ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressingscomposed of a calcium alginate pad presented on a visually clear, selfadherent, antimicrobial barrier film backing. ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected: - Pressure Ulcers - Venous Ulcers - Diabetic Ulcers - Arterial Ulcers - Donor Sites and other bleeding surface wounds - Dermal lesions, trauma injuries or incisions. ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.
    Device Description
    ARGLAES-AB™ Antimicrobial Barrier Film Dressings are sterile, visually clear, oxygen and moisture vapor permeable, and self-adherent dressings for use in wound care and venipuncture site management. ARGLAES-AB™ dressings are an effective protection against microbial contamination. ARGLAES-AB™ Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing. The ARGLAES-AB™ island dressing combines the advantages of a calcium alginate wound dressing together with ARGLAES-AB™ antimicrobial barrier film protection against wound site contamination.
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    K Number
    K973657
    Device Name
    ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
    Manufacturer
    MAERSK MEDICAL, LTD.
    Date Cleared
    1997-12-01

    (67 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAERSK MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected: - Pressure Ulcers - · Venous Ulcers - · Diabetic Ulcers - Arterial Ulcers - Donor Sites and other bleeding surface wounds - Dermal lesions, trauma injuries or incisions. ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.
    Device Description
    ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing.
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    K Number
    K970566
    Device Name
    ARGLAES FILM DRESSING
    Manufacturer
    MAERSK MEDICAL, LTD.
    Date Cleared
    1997-07-29

    (166 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAERSK MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.
    Device Description
    ARGLAES-AB Antimicrobial Barrier Film Dressing
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