BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biotronix Healthcare

    DI: 00850005165095 · Model: RE-343002S · BIOTRONIX HEALTHCARE INDUSTRIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Biotronix Healthcare
    Primary DI
    00850005165095
    Version / Model
    RE-343002S
    Catalog Number
    RE-343002S
    Company Name
    BIOTRONIX HEALTHCARE INDUSTRIES, INC.
    Labeler DUNS
    065762392
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-05
    Public Version
    2
    Public Version Date
    2019-12-24
    Public Version Status
    Update
    Public Device Record Key
    5bea9911-3b14-451c-bee9-f53db7f0029c

    Device Description

    Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    CAF Nebulizer (Direct Patient Interface)

    GMDN Terms

    Code Name
    31309 Nebulizing system delivery set, single-use

    Identifiers

    Type ID
    Package 10850005165092
    Primary 00850005165095

    Customer Contacts

    Phone
    786-473-9436
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K140237 000