BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    NA

    DI: 00816576020133 · Model: G146 · HARDY DIAGNOSTICS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    NA
    Primary DI
    00816576020133
    Version / Model
    G146
    Catalog Number
    G146
    Company Name
    HARDY DIAGNOSTICS
    Labeler DUNS
    039981550
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    4
    Public Version Date
    2020-03-31
    Public Version Status
    Update
    Public Device Record Key
    61d6b671-a429-4728-90c2-282097467953
    Distribution End Date
    2020-02-04

    Device Description

    MUELLER HINTON AGAR For the cultivation and maintenance of bacteria. Not intended for disk diffusion testing because of reduced fill.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

    GMDN Terms

    Code Name
    58639 Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

    Identifiers

    Type ID
    Primary 00816576020133
    Unit of Use 00816576021192

    Customer Contacts

    Phone
    800-266-2222
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K811646 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius