BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hybernite RT

    DI: 05404013000272 · Model: Hybernite RT 19 ex · Plastiflex Group NV
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Hybernite RT
    Primary DI
    05404013000272
    Version / Model
    Hybernite RT 19 ex
    Company Name
    Plastiflex Group NV
    Labeler DUNS
    371165452
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    6
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    643f6b72-a8fc-4328-a2a5-ef254f5b4437

    Device Characteristics

    Single Use
    Yes
    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
    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
    Package 15404013000279
    Primary 05404013000272