BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AVANOS*

    DI: 00193494468569 · Model: 46856 · Avanos Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AVANOS*
    Primary DI
    00193494468569
    Version / Model
    46856
    Catalog Number
    CB005C
    Company Name
    Avanos Medical, Inc.
    Labeler DUNS
    079375431
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-03
    Public Version
    2
    Public Version Date
    2023-06-22
    Public Version Status
    Update
    Public Device Record Key
    1d1f6f7d-4a9e-4b14-82c9-4aa7b93db1ec

    Device Description

    ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 1-7 ml/hr + 3 ml bolus/30 min

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MEB Pump, infusion, elastomeric

    GMDN Terms

    Code Name
    46542 Elastomeric infusion pump system

    Identifiers

    Type ID
    Package 10193494468566
    Primary 00193494468569

    Customer Contacts

    Phone
    +1(844)428-2667
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181360 000