BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vapotherm

    DI: 00841737102410 · Model: PF-DPC-Low-BR · VAPOTHERM, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vapotherm
    Primary DI
    00841737102410
    Version / Model
    PF-DPC-Low-BR
    Company Name
    VAPOTHERM, INC.
    Labeler DUNS
    040429050
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-31
    Public Version
    6
    Public Version Date
    2022-10-10
    Public Version Status
    Update
    Public Device Record Key
    fb2e90b4-de2d-4fc9-aa2d-0abb5fb5a33e

    Device Description

    Brazil Disposable Patient Circuit Low Flow

    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
    MR Unsafe
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    GMDN Terms

    Code Name
    57828 Professional high-flow respiratory unit, humidifying

    Identifiers

    Type ID
    Package 10841737102417
    Primary 00841737102410

    Premarket Submissions

    Submission Number Supplement Number
    K072845 000
    K111640 000