BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Flame photometer standard 140 Na 5K 1Li

    DI: 08426950037095 · Model: 00003331350 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Flame photometer standard 140 Na 5K 1Li
    Primary DI
    08426950037095
    Version / Model
    00003331350
    Catalog Number
    00003331350
    Company Name
    INSTRUMENTATION LABORATORY COMPANY
    Labeler DUNS
    557223252
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    6
    Public Version Date
    2021-07-07
    Public Version Status
    Update
    Public Device Record Key
    fb44fcae-6f85-4066-842a-57fc35ad188a
    Distribution End Date
    2019-09-24

    Device Description

    Flame photometer standard 140 Na 5K 1Li

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    No
    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
    JJO FLAME EMISSION PHOTOMETER FOR CLINICAL USE

    GMDN Terms

    Code Name
    52867 Multiple electrolyte IVD, calibrator

    Identifiers

    Type ID
    Primary 08426950037095
    Unit of Use 18426950037092

    Customer Contacts

    Phone
    1-800-678-0710
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K823480 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Calibration Standard 140/5/1 and 140/5 is stable until the expiration date if stored at 15-25 °C. The expiration date and lot number are printed on each vial and on the outer box