BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    S9

    DI: 00619498360000 · Model: 36000 · RESMED PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    S9
    Primary DI
    00619498360000
    Version / Model
    36000
    Catalog Number
    36000
    Company Name
    RESMED PTY LTD
    Labeler DUNS
    751149311
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-26
    Public Version
    3
    Public Version Date
    2021-07-23
    Public Version Status
    Update
    Public Device Record Key
    0349b68d-f1fc-49d3-9173-abfc608ff47d

    Device Description

    S9 VPAP TX CLINICAL SYSTEM KIT

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MNS Ventilator, Continuous, Non-Life-Supporting

    GMDN Terms

    Code Name
    60712 Home BPAP unit

    Identifiers

    Type ID
    Primary 00619498360000

    Customer Contacts

    Phone
    800-424-0737
    Email
    [email protected]