BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N Cuvette Segments for BN II

    DI: 00842768012167 · Model: 10446520 · Siemens Healthcare Diagnostics Products GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    60

    Basic Information

    Brand Name
    N Cuvette Segments for BN II
    Primary DI
    00842768012167
    Version / Model
    10446520
    Catalog Number
    OVIB31
    Company Name
    Siemens Healthcare Diagnostics Products GmbH
    Labeler DUNS
    388240673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    60
    Record Status
    Published
    Publish Date
    2017-11-15
    Public Version
    5
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    19aa22c2-7673-4225-b00c-ca1d82736de4

    Device Description

    The N-cuvettessegment is an consumable in the BNII system.

    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
    DEW IGG, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    56728 Nephelometry immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 00842768012167
    Unit of Use 00842768024771

    Customer Contacts

    Phone
    +1(800)664-3822
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K943997 000