BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smart-Well Incubator

    DI: M9859990280090 · Model: 1710 · MESA LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Smart-Well Incubator
    Primary DI
    M9859990280090
    Version / Model
    1710
    Catalog Number
    999-028-999
    Company Name
    MESA LABORATORIES, INC.
    Labeler DUNS
    102530326
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-16
    Public Version
    1
    Public Version Date
    2018-11-16
    Public Version Status
    New
    Public Device Record Key
    dcae3c5d-7b73-4a92-82f6-e3cafe2dcaf9

    Device Description

    The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). Each incubator cavity has an electronic monitoring system that detects if the BI is either purple or yellow.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    FRC Indicator, Biological Sterilization Process

    GMDN Terms

    Code Name
    13732 Biological sterilization indicator

    Identifiers

    Type ID
    Primary M9859990280090

    Premarket Submissions

    Submission Number Supplement Number
    K122362 000