BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ActiGraph

    DI: 00853048008022 · Model: CentrePoint Data Hub · ACTIGRAPH L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ActiGraph
    Primary DI
    00853048008022
    Version / Model
    CentrePoint Data Hub
    Company Name
    ACTIGRAPH L.L.C.
    Labeler DUNS
    144830952
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    94b7c6f5-86c5-4d25-affe-5b37570b3048

    Device Description

    The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.

    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
    Yes
    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
    OUG Medical Device Data System

    GMDN Terms

    Code Name
    62115 Ambulatory monitoring/recording system transceiver/cable

    Identifiers

    Type ID
    Primary 00853048008022