BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Advance Plus™ Earloop Procedure Masks

    DI: 10810012650035 · Model: ADV2316 · SOUTHERN ANESTHESIA & SURGICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Advance Plus™ Earloop Procedure Masks
    Primary DI
    10810012650035
    Version / Model
    ADV2316
    Catalog Number
    ADV2316
    Company Name
    SOUTHERN ANESTHESIA & SURGICAL, INC.
    Labeler DUNS
    119186732
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2020-03-10
    Public Version
    2
    Public Version Date
    2020-05-06
    Public Version Status
    Update
    Public Device Record Key
    5734bb4f-ee44-42bd-af50-6ce53ba0123a

    Device Description

    Earloop Procedure Masks, ASTM Level 3, Blue, Box

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    FXX Mask, Surgical

    GMDN Terms

    Code Name
    35177 Surgical/medical face mask, single-use

    Identifiers

    Type ID
    Package 20810012650032
    Primary 10810012650035
    Unit of Use 00810012650038

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 40 Degrees Celsius