BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    JOHN BUNN

    DI: M368JB01120671 · Model: JB0112-067 · GF HEALTH PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    JOHN BUNN
    Primary DI
    M368JB01120671
    Version / Model
    JB0112-067
    Company Name
    GF HEALTH PRODUCTS, INC.
    Labeler DUNS
    132016168
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    5
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    21126d44-a033-4eed-a5ae-082cb3e9017e

    Device Description

    NEB-U-TYKE SPEEDSTER

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    35457 Benchtop nebulizer, non-heated

    Identifiers

    Type ID
    Package M368JB01120672
    Primary M368JB01120671

    Customer Contacts

    Phone
    770-368-4700
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K052811 000