BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MIRI Time-Lapse Incubator

    DI: 04779041940311 · Model: MIRI TL12 · ESCO MEDICAL TECHNOLOGIES UAB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MIRI Time-Lapse Incubator
    Primary DI
    04779041940311
    Version / Model
    MIRI TL12
    Company Name
    ESCO MEDICAL TECHNOLOGIES UAB
    Labeler DUNS
    365831125
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-15
    Public Version
    1
    Public Version Date
    2026-01-23
    Public Version Status
    New
    Public Device Record Key
    82592e15-d92c-4846-adb4-07d030f7fc03

    Device Description

    Esco Medical MIRI® TL family`s multiroom IVF incubators are intended to provide an environment with controlled temperature, CO2 and other gases for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. The device use is limited up to six days (199 hours), covering the time from post-fertilization to day 6 of the development.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PUB Accessory, Assisted Reproduction, Exempt

    GMDN Terms

    Code Name
    35482 Aerobic laboratory incubator

    Identifiers

    Type ID
    Primary 04779041940311