BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BACT/ALERT® 3D LEFT INCUBATION MODULE

    DI: 03573026049577 · Model: 210159 · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BACT/ALERT® 3D LEFT INCUBATION MODULE
    Primary DI
    03573026049577
    Version / Model
    210159
    Company Name
    BIOMERIEUX , INC.
    Labeler DUNS
    086785110
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-23
    Public Version
    3
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    10386246-bd03-453c-93a0-d187491f551f

    Device Description

    the BacT/ALERT 3D Left Incubator Module has four independent drawers of 60 cells each. Patented cell flags track bottle movements between cells for greater ease of use.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MDB System, blood culturing

    GMDN Terms

    Code Name
    56739 Blood culture analyser IVD

    Identifiers

    Type ID
    Primary 03573026049577

    Premarket Submissions

    Submission Number Supplement Number
    K903505 000
    K981736 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 50 Degrees Celsius