BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MARTIN LEWIS AGAR

    DI: M20210951 · Model: 1095 · Healthlink
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    MARTIN LEWIS AGAR
    Primary DI
    M20210951
    Version / Model
    1095
    Catalog Number
    1095
    Company Name
    Healthlink
    Labeler DUNS
    079376107
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    e517a623-f862-4335-b82e-739650e75f60

    Device Description

    MARTIN LEWIS AGAR

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JTY CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

    GMDN Terms

    Code Name
    58646 Neiserria species agar culture medium IVD, basic

    Identifiers

    Type ID
    Package M20210952
    Primary M20210951
    Unit of Use M20210950

    Customer Contacts

    Phone
    +1(800)638-2625
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K950196 000

    Device Sizes

    Type Value Unit Text
    Outer Diameter 100 Millimeter
    Device Size Text, specify 100 mm

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius