BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AIR 11

    DI: 00619498390045 · Model: 39004 · RESMED PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AIR 11
    Primary DI
    00619498390045
    Version / Model
    39004
    Catalog Number
    39004
    Company Name
    RESMED PTY LTD
    Labeler DUNS
    751149311
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-25
    Public Version
    2
    Public Version Date
    2021-07-23
    Public Version Status
    Update
    Public Device Record Key
    6230df14-077b-43b0-8cd2-01730d05e984

    Device Description

    AirSense 11 Elite USA CO

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZD Ventilator, Non-Continuous (Respirator)

    GMDN Terms

    Code Name
    60711 Home CPAP unit

    Identifiers

    Type ID
    Primary 00619498390045

    Customer Contacts

    Phone
    800-427-0737
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    5 – 95 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -13 – 158 Degrees Fahrenheit