BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pneumotrac

    DI: 05099169770010 · Model: 6800 · VITALOGRAPH (IRELAND) LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pneumotrac
    Primary DI
    05099169770010
    Version / Model
    6800
    Company Name
    VITALOGRAPH (IRELAND) LIMITED
    Labeler DUNS
    219683489
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-15
    Public Version
    6
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    ccea4703-57d0-4edc-918a-bf87fb14d09d

    Device Description

    6800 PNEUMOTRAC USA

    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
    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
    13680 Diagnostic spirometer, professional

    Identifiers

    Type ID
    Primary 05099169770010

    Premarket Submissions

    Submission Number Supplement Number
    K141546 000
    K142812 000