BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AU

    DI: 15099590010270 · Model: OSR6130 · 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
    AU
    Primary DI
    15099590010270
    Version / Model
    OSR6130
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    6d390515-c260-4582-ad09-21720cbc6205

    Device Description

    Lipase

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

    GMDN Terms

    Code Name
    53108 Lipase IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 15099590010270

    Premarket Submissions

    Submission Number Supplement Number
    K963424 000