BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)

    DI: 00816310022997 · Model: ED3000 · DANLEE MEDICAL PRODUCTS, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)
    Primary DI
    00816310022997
    Version / Model
    ED3000
    Company Name
    DANLEE MEDICAL PRODUCTS, INC
    Labeler DUNS
    878130871
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-23
    Public Version
    1
    Public Version Date
    2020-07-01
    Public Version Status
    New
    Public Device Record Key
    82d8f5a9-7fcc-4c05-a3eb-4b92177407fe

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    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
    DRX Electrode, Electrocardiograph

    GMDN Terms

    Code Name
    35035 Electrocardiographic electrode, single-use

    Identifiers

    Type ID
    Primary 00816310022997
    Package 10816310022994
    Package 20816310022991

    Premarket Submissions

    Submission Number Supplement Number
    K931457 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    41 – 86 Degrees Fahrenheit