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510(k) Data Aggregation

    K Number
    K964398
    Device Name
    SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
    Date Cleared
    1997-10-24

    (354 days)

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

    POLYMEDICA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SPYROFLEX Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes
    Device Description
    SPYROFLEX® is a sterile, conformable, absorptive dressing. SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment. The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.
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    K Number
    K971045
    Device Name
    BASIS FLEXIBLE TIP DIGITAL THERMOMETER
    Date Cleared
    1997-05-02

    (42 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDICA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
    Device Description
    The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".
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    K Number
    K964701
    Device Name
    MITRAFLEX PIGMENTED WOUND DRESSING
    Date Cleared
    1997-02-07

    (74 days)

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

    POLYMEDICA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MITRAFLEX Pigmented Wound Dressings are intended for use in the management of: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Dermabrasions and other dermatologic procedures, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns, Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
    Device Description
    MITRAFLEX Pigmented Wound Dressings are sterile, absorptive dressings. MITRAFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. MITRAFLEX dressings are constructed of three layers, each specifically engineered to give MITRAFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing. The wound contact surface of MITRAFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. MITRAFLEX is impermeable to microorganisms and liquids.
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    K Number
    K963623
    Device Name
    SPYROFLEX PIGMENTED WOUND DRESSING
    Date Cleared
    1996-10-25

    (44 days)

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

    POLYMEDICA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SPYROFLEX Pigmented Wound Dressings are intended for use in the management of. Venous stasis ulcers Diabetic ulcers Pressure sores Donor sites Blisters Incisions Severe sunburn Poison Ivy Dermabrasions and other dermatologic procedures Facelifts and other plastic surgery procedures (e.g. laser resurfacing) Partial-thickness wounds Superficial burns Abrasions and lacerations Full-thickness wounds Skin tears Dermal lesions Minor chemical burns Thermal burns
    Device Description
    SPYROFLEX Pigmented Wound Dressings are sterile, absorptive dressings. SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing. The wound contact surface of SPYROFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. SPYROFLEX is impermeable to microorganisms and liquids.
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    K Number
    K962991
    Device Name
    BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
    Date Cleared
    1996-09-12

    (42 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDICA INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
    Device Description
    The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
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