BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Stool Preparation Set

    DI: 04099466400116 · Model: ACS-001 · Seramun Diagnostica GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Stool Preparation Set
    Primary DI
    04099466400116
    Version / Model
    ACS-001
    Company Name
    Seramun Diagnostica GmbH
    Labeler DUNS
    344006309
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-21
    Public Version
    1
    Public Version Date
    2024-11-29
    Public Version Status
    New
    Public Device Record Key
    ff30c6fb-4b1d-4741-b259-de186ff5387b

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    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
    LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

    GMDN Terms

    Code Name
    53145 Pancreatic elastase (PE) IVD, reagent

    Identifiers

    Type ID
    Primary 04099466400116