BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Synchron

    DI: 15099590222017 · Model: 474985 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Synchron
    Primary DI
    15099590222017
    Version / Model
    474985
    Catalog Number
    474985
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d5327ee5-680a-4678-bdda-14369ff44e69

    Device Description

    SYNCHRON Systems OP 300 High Urine Calibrator

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    DLJ Calibrators, Drug Specific

    GMDN Terms

    Code Name
    55722 Opiate/opiate metabolite IVD, calibrator

    Identifiers

    Type ID
    Primary 15099590222017

    Premarket Submissions

    Submission Number Supplement Number
    K993022 000