BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VITEK® 2 AST-N804

    DI: 03573026634780 · Model: VITEK® 2 AST-N804 · BIOMERIEUX , INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VITEK® 2 AST-N804
    Primary DI
    03573026634780
    Version / Model
    VITEK® 2 AST-N804
    Company Name
    BIOMERIEUX , INC.
    Labeler DUNS
    086785110
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-30
    Public Version
    1
    Public Version Date
    2023-07-10
    Public Version Status
    New
    Public Device Record Key
    261e5abe-c315-4e2f-8ec8-d66bdbb2e6b0

    Device Description

    VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli

    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
    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
    LON SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

    GMDN Terms

    Code Name
    58605 General-microorganism antimicrobial susceptibility culture medium IVD

    Identifiers

    Type ID
    Package 03573026634797
    Primary 03573026634780

    Premarket Submissions

    Submission Number Supplement Number
    K072038 000
    K091899 000
    K103752 000
    K110106 000
    K113200 000
    K161227 000
    K161510 000
    K162737 000
    K163006 000
    K163083 000
    K163563 000
    K172731 000
    N50510 082
    N50510 093
    N50510 097
    N50510 115

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius