BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Medical Specialties, Inc.

    DI: 00815849020337 · Model: CMS-954P · CUSTOM ASSEMBLIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Custom Medical Specialties, Inc.
    Primary DI
    00815849020337
    Version / Model
    CMS-954P
    Company Name
    CUSTOM ASSEMBLIES, INC.
    Labeler DUNS
    948904735
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-22
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b0391262-dba5-4f05-9909-40bf35c3c1f7

    Device Description

    Polyvinyl Urological Drainage Bag for GE/OEC Systems - Non-Sterile

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BWN Table And Attachments, Operating-Room

    GMDN Terms

    Code Name
    58982 Surgical tissue/fluid collection bag, non-sterile

    Identifiers

    Type ID
    Package 00815849020894
    Primary 00815849020337