BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hybernite RT

    DI: 05404013003693 · Model: RT 114 Convenience kit · Plastiflex Group NV
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hybernite RT
    Primary DI
    05404013003693
    Version / Model
    RT 114 Convenience kit
    Catalog Number
    HFN19022BT1STWGO
    Company Name
    Plastiflex Group NV
    Labeler DUNS
    371165452
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-09
    Public Version
    2
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    09ea5ca1-7913-4880-b6e0-6a2360be5a8f

    Device Description

    Hybernite RT 114 Convenience kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 05404013003693
    Package 15404013003690