BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVANCED CENTRAL MONITORING STATION

    DI: B510CMS1000FM1 · Model: CMS-1000FM · ADVANCED INSTRUMENTATIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ADVANCED CENTRAL MONITORING STATION
    Primary DI
    B510CMS1000FM1
    Version / Model
    CMS-1000FM
    Company Name
    ADVANCED INSTRUMENTATIONS, INC.
    Labeler DUNS
    608736880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-17
    Public Version
    2
    Public Version Date
    2020-05-19
    Public Version Status
    Update
    Public Device Record Key
    bc8ce871-3925-4ecf-83fe-a2532054759e
    Distribution End Date
    2028-04-15

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    HGM System, Monitoring, Perinatal

    GMDN Terms

    Code Name
    38470 Centralized patient monitor

    Identifiers

    Type ID
    Primary B510CMS1000FM1

    Premarket Submissions

    Submission Number Supplement Number
    K112159 000