BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nuprep Skin Prep Gel

    DI: 00891893002284 · Model: 10-91; 10-91K · D. O. WEAVER AND COMPANY
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nuprep Skin Prep Gel
    Primary DI
    00891893002284
    Version / Model
    10-91; 10-91K
    Company Name
    D. O. WEAVER AND COMPANY
    Labeler DUNS
    039143201
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-17
    Public Version
    1
    Public Version Date
    2023-11-27
    Public Version Status
    New
    Public Device Record Key
    b5bcc264-ddb0-4fe2-beae-dee1cee70ccd

    Device Description

    Single-use cup of Nuprep Skin Prep Gel (unit of use)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    11425 Electrode conductive medium

    Identifiers

    Type ID
    Package 10891893002281
    Primary 00891893002284
    Package 20891893002288
    Package 30891893002285

    Customer Contacts

    Phone
    8005252130
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K885306 000