BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TeleRPM & Chronica

    DI: 00850042929216 · Model: TCS01 · Mio Labs Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TeleRPM & Chronica
    Primary DI
    00850042929216
    Version / Model
    TCS01
    Company Name
    Mio Labs Inc.
    Labeler DUNS
    117119317
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-01
    Public Version
    2
    Public Version Date
    2023-11-13
    Public Version Status
    Update
    Public Device Record Key
    a2ce6bb7-4696-4d70-a354-a2858965586e

    Device Description

    TeleRPM Control Solution

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00850042929216