BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BodyGuard 121 pump

    DI: B101100105TSA0 · Model: 100-105TSA · CME AMERICA LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BodyGuard 121 pump
    Primary DI
    B101100105TSA0
    Version / Model
    100-105TSA
    Company Name
    CME AMERICA LLC
    Labeler DUNS
    002125419
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    6
    Public Version Date
    2022-09-23
    Public Version Status
    Update
    Public Device Record Key
    d26106db-b384-4630-8d22-c9c8b8ddb135
    Distribution End Date
    2020-10-15

    Device Characteristics

    Single Use
    No
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRN Pump, Infusion
    MEA Pump, Infusion, Pca

    GMDN Terms

    Code Name
    17634 Bedside infusion pump, multichannel

    Identifiers

    Type ID
    Primary B101100105TSA0

    Customer Contacts

    Phone
    303-936-4945
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -13 – 122 Degrees Fahrenheit