BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CustoMed

    DI: 74895237104134 · Model: 1 · KENPAX INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CustoMed
    Primary DI
    74895237104134
    Version / Model
    1
    Catalog Number
    68-324B-PC
    Company Name
    KENPAX INTERNATIONAL LIMITED
    Labeler DUNS
    686206765
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-16
    Public Version
    2
    Public Version Date
    2021-12-22
    Public Version Status
    Update
    Public Device Record Key
    32206372-12a9-4927-a333-7ad438d543ae

    Device Description

    Bouffant cap A non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LYU Accessory, Surgical Apparel

    GMDN Terms

    Code Name
    32297 Surgical cap, single-use

    Identifiers

    Type ID
    Package 84895237141136
    Primary 74895237104134