BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Model 4000

    DI: 15099169400396 · Model: 4000 · VITALOGRAPH (IRELAND) LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Model 4000
    Primary DI
    15099169400396
    Version / Model
    4000
    Company Name
    VITALOGRAPH (IRELAND) LIMITED
    Labeler DUNS
    219683489
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-08
    Public Version
    4
    Public Version Date
    2021-03-19
    Public Version Status
    Update
    Public Device Record Key
    69c27439-6165-4fd7-aa81-2cf72861d75b

    Device Description

    4000 RESPIRATORY MONITOR ASMA-1 JAPAN

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    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
    Package 05099169400399
    Primary 15099169400396
    Package 35099169400390

    Premarket Submissions

    Submission Number Supplement Number
    K073155 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 50 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity