BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HUDSON RCI

    DI: 10801902126532 · Model: IPN053908 · TELEFLEX INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HUDSON RCI
    Primary DI
    10801902126532
    Version / Model
    IPN053908
    Catalog Number
    880-37
    Company Name
    TELEFLEX INCORPORATED
    Labeler DUNS
    002348191
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    5
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    dfa5144a-3d22-4e57-8b33-23a500c508b5

    Device Description

    Adult ISO-GARD Breathing Circuit with Dual Heated Limbs

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BTT HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Package 40801902126533
    Primary 10801902126532

    Customer Contacts

    Phone
    +1(919)544-8000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K140556 000