BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BCI

    DI: 35019517062247 · Model: WW1131 · SMITHS MEDICAL MD, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    BCI
    Primary DI
    35019517062247
    Version / Model
    WW1131
    Company Name
    SMITHS MEDICAL MD, INC.
    Labeler DUNS
    106712748
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-10-11
    Public Version
    6
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    866709de-e0ac-4670-8ed5-2676f4bb313c

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

    GMDN Terms

    Code Name
    36872 Multiple vital physiological parameter monitoring system, clinical

    Identifiers

    Type ID
    Primary 35019517062247
    Unit of Use 15019517062243

    Premarket Submissions

    Submission Number Supplement Number
    K863883 000