BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MIR

    DI: 08052990320486 · Model: MIR SPIROTEL SPIROMETER · MIR MEDICAL INTERNATIONAL RESEARCH SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MIR
    Primary DI
    08052990320486
    Version / Model
    MIR SPIROTEL SPIROMETER
    Company Name
    MIR MEDICAL INTERNATIONAL RESEARCH SPA
    Labeler DUNS
    630129930
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-06
    Public Version
    6
    Public Version Date
    2024-01-12
    Public Version Status
    Update
    Public Device Record Key
    0710ddb1-735e-4618-9a43-5b5850cc05e3

    Device Description

    Portable spirometer for lung function testing

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    BZG Spirometer, Diagnostic

    GMDN Terms

    Code Name
    46906 Expiratory peak flow meter, digital

    Identifiers

    Type ID
    Primary 08052990320486

    Customer Contacts

    Phone
    +390622754777
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K130784 000