BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Aspiration and Flush Assembly

    DI: H862AFA20P0 · Model: AFA-20P · URESIL, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Aspiration and Flush Assembly
    Primary DI
    H862AFA20P0
    Version / Model
    AFA-20P
    Catalog Number
    AFA-20P
    Company Name
    URESIL, LLC
    Labeler DUNS
    192559557
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-24
    Public Version
    6
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    095ab376-34a9-4b5d-a5c8-d0f8bf5c4d92
    Distribution End Date
    2020-01-21

    Device Description

    ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GBO Catheter, Nephrostomy, General & Plastic Surgery

    GMDN Terms

    Code Name
    64467 Luer/non-ISO80369-standardized linear connector, single-use

    Identifiers

    Type ID
    Package H862AFA20P2
    Package H862AFA20P1
    Primary H862AFA20P0

    Customer Contacts

    Phone
    1-800-538-7374
    Email
    [email protected]