BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    mcompass ARM and BIofeedback System

    DI: 00851607003273 · Model: RMD-003 · MEDSPIRA, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    mcompass ARM and BIofeedback System
    Primary DI
    00851607003273
    Version / Model
    RMD-003
    Company Name
    MEDSPIRA, LLC
    Labeler DUNS
    962187964
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-26
    Public Version
    2
    Public Version Date
    2021-04-09
    Public Version Status
    Update
    Public Device Record Key
    62adbaaa-1b1e-4b79-8239-aa9c1cc9b0b7

    Device Description

    Medspira Anorectal Manometry and Biofeedback System

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    35053 Manometric gastrointestinal motility analysis system

    Identifiers

    Type ID
    Primary 00851607003273
    Package 10851607003270

    Customer Contacts

    Phone
    612-789-0013
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K143031 000