BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    API® NaCl 0.85% Medium

    DI: 03573026588472 · Model: API® NaCL 0.85% Medium, 2 ml · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    API® NaCl 0.85% Medium
    Primary DI
    03573026588472
    Version / Model
    API® NaCL 0.85% Medium, 2 ml
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-10
    Public Version
    2
    Public Version Date
    2021-12-09
    Public Version Status
    Update
    Public Device Record Key
    8a589a3d-6944-434a-b23a-e7f056078162

    Device Description

    NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JTO DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

    GMDN Terms

    Code Name
    50416 Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

    Identifiers

    Type ID
    Package 03573026047771
    Primary 03573026588472

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius