BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASP MEDICAL

    DI: 00840216109032 · Model: FMT650A · Asp Global, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ASP MEDICAL
    Primary DI
    00840216109032
    Version / Model
    FMT650A
    Company Name
    Asp Global, LLC
    Labeler DUNS
    080361159
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-19
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    e04fc03b-3f2f-4a9b-b2bf-97df1aef88f5

    Device Description

    MASK, FACE, BLUE, EARLOOPS, ANTI-FOG FOAM, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER) LEVEL 3

    Device Characteristics

    Single Use
    Yes
    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
    FXX Mask, Surgical

    GMDN Terms

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

    Identifiers

    Type ID
    Package 10840216109039
    Primary 00840216109032
    Package 20840216109036