BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BodyGuard® Microset with Filter

    DI: B101A120160XSFE0 · Model: A120-160XSFE · CME AMERICA LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BodyGuard® Microset with Filter
    Primary DI
    B101A120160XSFE0
    Version / Model
    A120-160XSFE
    Company Name
    CME AMERICA LLC
    Labeler DUNS
    002125419
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-22
    Public Version
    4
    Public Version Date
    2020-07-09
    Public Version Status
    Update
    Public Device Record Key
    9801728c-f905-4e56-94b6-ea628cbd9c7f
    Distribution End Date
    2019-11-04

    Device Description

    134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump

    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
    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
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package B101A120160XSFE1
    Primary B101A120160XSFE0

    Customer Contacts

    Phone
    303-936-4945
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K042696 000