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510(k) Data Aggregation
K Number
K004028Device Name
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
Manufacturer
MAERSK MEDICAL, LTD.
Date Cleared
2001-03-27
(90 days)
Product Code
FRO
Regulation Number
N/AWhy 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
K990810Device 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/AWhy 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
K973657Device Name
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
Manufacturer
MAERSK MEDICAL, LTD.
Date Cleared
1997-12-01
(67 days)
Product Code
MGP
Regulation Number
N/AWhy 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
K970566Device Name
ARGLAES FILM DRESSING
Manufacturer
MAERSK MEDICAL, LTD.
Date Cleared
1997-07-29
(166 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy 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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