BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dale PediPrints

    DI: H84102411 · Model: 241 · Dale Medical Products, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Dale PediPrints
    Primary DI
    H84102411
    Version / Model
    241
    Catalog Number
    241
    Company Name
    Dale Medical Products, Inc.
    Labeler DUNS
    001061233
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-27
    Public Version
    3
    Public Version Date
    2024-04-22
    Public Version Status
    Update
    Public Device Record Key
    ff917876-9612-41ca-b314-9e8cf1a9981c

    Device Description

    Dale PediPrints Tracheostomy Tube Holder, 1" wide, fits up to 18" neck

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBH Device, Fixation, Tracheal Tube

    GMDN Terms

    Code Name
    35752 Tracheostomy tube neck holder, reusable

    Identifiers

    Type ID
    Package H84102412
    Primary H84102411