BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vapotherm

    DI: 00841737103059 · Model: PF-OAMDPC-LOW · VAPOTHERM, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vapotherm
    Primary DI
    00841737103059
    Version / Model
    PF-OAMDPC-LOW
    Company Name
    VAPOTHERM, INC.
    Labeler DUNS
    040429050
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-08
    Public Version
    3
    Public Version Date
    2022-10-10
    Public Version Status
    Update
    Public Device Record Key
    2d5322b2-abc4-427d-8e33-e565a7c421a6

    Device Description

    Precision Flow Oxygen Assist Module, DPC LOW

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    QAV High Flow/High Velocity Humidified Oxygen Delivery Device
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    GMDN Terms

    Code Name
    57828 Professional high-flow respiratory unit, humidifying

    Identifiers

    Type ID
    Package 10841737103056
    Primary 00841737103059