BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visby Medical Respiratory Health

    DI: 00810031720019 · Model: PS-300708 · Visby Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visby Medical Respiratory Health
    Primary DI
    00810031720019
    Version / Model
    PS-300708
    Catalog Number
    PS-400005
    Company Name
    Visby Medical, Inc.
    Labeler DUNS
    933894748
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-19
    Public Version
    1
    Public Version Date
    2025-03-27
    Public Version Status
    New
    Public Device Record Key
    b737dd73-63eb-4deb-94a8-012adfc2941d

    Device Characteristics

    Single Use
    Yes
    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
    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
    QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

    GMDN Terms

    Code Name
    47922 Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Package 10810031720016
    Primary 00810031720019