BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Splash Shield Lite

    DI: 00781963454078 · Model: 4540LBMU · BERKLEY MEDICAL RESOURCES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Splash Shield Lite
    Primary DI
    00781963454078
    Version / Model
    4540LBMU
    Company Name
    BERKLEY MEDICAL RESOURCES, INC.
    Labeler DUNS
    077359201
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-05
    Public Version
    3
    Public Version Date
    2020-04-06
    Public Version Status
    Update
    Public Device Record Key
    3be3b4c0-b89e-40a3-8076-a8d694f0e4e3

    Device Description

    Sold as box of 40

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FXX Mask, Surgical

    GMDN Terms

    Code Name
    11961 Face splash shield, single-use

    Identifiers

    Type ID
    Primary 00781963454078