BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Guardian Angel™ Rx

    DI: 04719872650058 · Model: GA1000-A · AULISA MEDICAL USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Guardian Angel™ Rx
    Primary DI
    04719872650058
    Version / Model
    GA1000-A
    Company Name
    AULISA MEDICAL USA, INC.
    Labeler DUNS
    116820893
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-13
    Public Version
    3
    Public Version Date
    2019-12-16
    Public Version Status
    Update
    Public Device Record Key
    4ac21ace-6d04-4a27-ab1d-9e0f370f412d
    Distribution End Date
    2019-05-17

    Device Description

    Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQA Oximeter

    GMDN Terms

    Code Name
    36118 Pulse oximetry telemetric monitoring system

    Identifiers

    Type ID
    Package 14719872650055
    Primary 04719872650058