BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Screening Center

    DI: 06438147320905 · Model: 5002-0500 · Wallac Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Screening Center
    Primary DI
    06438147320905
    Version / Model
    5002-0500
    Catalog Number
    5002-0500
    Company Name
    Wallac Oy
    Labeler DUNS
    540156544
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-25
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    26490750-5e84-4a78-be8e-daead5bfbdb2

    Device Description

    Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JQP Calculator/Data Processing Module, For Clinical Use

    GMDN Terms

    Code Name
    35477 Clinical laboratory information system

    Identifiers

    Type ID
    Primary 06438147320905