BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Factor 14

    DI: 00860014139109 · Model: Afterburner · FACTOR 14 LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Factor 14
    Primary DI
    00860014139109
    Version / Model
    Afterburner
    Company Name
    FACTOR 14 LLC
    Labeler DUNS
    119521026
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-16
    Public Version
    1
    Public Version Date
    2025-06-24
    Public Version Status
    New
    Public Device Record Key
    1432842f-fb99-4fb5-a40b-8f1fb2caafb1
    Distribution End Date
    2027-06-16

    Device Description

    4 Ounce bottle with sprayer filled with Hypochlorous Acid Gel formula. Over the counter formula.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRO Dressing, Wound, Drug

    GMDN Terms

    Code Name
    59523 Antimicrobial wound irrigation solution

    Identifiers

    Type ID
    Primary 00860014139109