BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Custom Medical Specialties

    DI: 00815849023253 · Model: CMS-1213 · 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
    Primary DI
    00815849023253
    Version / Model
    CMS-1213
    Company Name
    CUSTOM ASSEMBLIES, INC.
    Labeler DUNS
    948904735
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-25
    Public Version
    4
    Public Version Date
    2021-07-19
    Public Version Status
    Update
    Public Device Record Key
    9472369c-6ad3-480b-baae-45d7a6a0c54e

    Device Description

    Large Bore Infiltration Set - 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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    58977 Basic intravenous administration set, noninvasive

    Identifiers

    Type ID
    Package 00815849023277
    Primary 00815849023253

    Premarket Submissions

    Submission Number Supplement Number
    K993463 000