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    K Number
    K231123
    Device Name
    Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
    Manufacturer
    Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
    Date Cleared
    2023-08-30

    (132 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
    Device Description
    There are three models of the Phoenix Contact Lens Case: CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural. The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.
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    K Number
    K201032
    Device Name
    Phoenix Digital Thermometer
    Manufacturer
    Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
    Date Cleared
    2021-10-29

    (557 days)

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

    Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.
    Device Description
    Not Found
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