BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Core Values

    DI: 00034197008709 · Model: 8709 · HARMON STORES, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Core Values
    Primary DI
    00034197008709
    Version / Model
    8709
    Company Name
    HARMON STORES, INC.
    Labeler DUNS
    804085293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8ccd7699-2d95-4775-a634-b9537cec9b34

    Device Description

    Saline Wound Wash

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRO Dressing, Wound, Drug
    FQH Lavage, Jet

    GMDN Terms

    Code Name
    37298 Wound irrigation sterile saline

    Identifiers

    Type ID
    Package 10034197008706
    Primary 00034197008709

    Customer Contacts

    Phone
    718-878-3097
    Email
    [email protected]
    Phone
    718-690-7099
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    33 – 120 Degrees Fahrenheit