BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    G210 InviCell Standard Incubator

    DI: 05060554120123 · Model: G210 · RESEARCH INSTRUMENTS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    G210 InviCell Standard Incubator
    Primary DI
    05060554120123
    Version / Model
    G210
    Catalog Number
    K59500
    Company Name
    RESEARCH INSTRUMENTS LIMITED
    Labeler DUNS
    536139413
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-19
    Public Version
    1
    Public Version Date
    2024-09-27
    Public Version Status
    New
    Public Device Record Key
    12fc5c7f-231d-401e-bab5-c76dcf4ea736

    Device Description

    IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    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
    44290 Assisted reproduction heater/incubator

    Identifiers

    Type ID
    Primary 05060554120123