BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Hct Calibrator

    DI: 08426950046677 · Model: 00009832550 · INSTRUMENTATION LABORATORY COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    Hct Calibrator
    Primary DI
    08426950046677
    Version / Model
    00009832550
    Catalog Number
    00009832550
    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
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    682e2318-7aa8-4776-bd2b-ef4e6c94f0b8
    Distribution End Date
    2018-03-09

    Device Description

    HCT CALIBRATOR 14 1600 SYNTH 50X2ML

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    JIS CALIBRATOR, PRIMARY

    GMDN Terms

    Code Name
    55876 Multiple haemoglobin subtype IVD, kit, electrophoresis

    Identifiers

    Type ID
    Primary 08426950046677
    Unit of Use 18426950046674

    Customer Contacts

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

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Hct check controls are stable until the expiration date shown on the ampule label when stored at 15-25 °C