BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ambIT* Cassette - Filter, Male Neuraxial Connector

    DI: 00193494000387 · Model: 220523 · Avanos Medical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ambIT* Cassette - Filter, Male Neuraxial Connector
    Primary DI
    00193494000387
    Version / Model
    220523
    Catalog Number
    220523
    Company Name
    Avanos Medical, Inc.
    Labeler DUNS
    079375431
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-17
    Public Version
    2
    Public Version Date
    2023-06-22
    Public Version Status
    Update
    Public Device Record Key
    f1895bb8-e788-4658-af32-b8a86116006d

    Device Description

    ambIT* Cassette - Filter, Male Neuraxial Connector

    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
    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
    FRN Pump, infusion
    MEA Pump, infusion, pca

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package 20193494000381
    Package 10193494000384
    Primary 00193494000387

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K162165 000