BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InSure FIT

    DI: 00850093003095 · Model: 01 · ENTERIX INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InSure FIT
    Primary DI
    00850093003095
    Version / Model
    01
    Catalog Number
    14103
    Company Name
    ENTERIX INC.
    Labeler DUNS
    002224009
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    b3c44e8f-fb7a-4782-91b9-4ac13f9db91a

    Device Description

    InSure FIT Run Buffer - 1 Liter Bottle

    Device Characteristics

    Single Use
    Yes
    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
    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
    KHE Reagent, Occult Blood

    GMDN Terms

    Code Name
    54533 Faecal occult blood IVD, reagent

    Identifiers

    Type ID
    Primary 00850093003095

    Premarket Submissions

    Submission Number Supplement Number
    K002457 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    36 – 46 Degrees Fahrenheit