BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ambIT PIB

    Reg #: 3011270181 · FEI: 3011270181 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Avanos Medical, Inc. (Formerly Halyard Health Inc.)
    Registration Number
    3011270181
    FEI Number
    3011270181
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5405 Windward Parkway
    City
    Alpharetta
    State
    GA
    ZIP
    30004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162165

    Owner / Operator

    Firm Name
    Avanos Medical, Inc.
    Operator Number
    2022573
    Address
    5405 Windward Parkway, --
    City
    Alpharetta
    State
    GA
    Postal Code
    30004
    Country
    US

    Products

    Device Name Product Code
    Pump, Infusion FRN
    Pump, Infusion, Pca MEA

    Proprietary Names

    ambIT PIB ambIT PIB/PCA v 1.5 ambIT PIB*PCA PIB IL KIDS PIB ambIT Programmable Intermittent Pump ambIT PIEB ambIT PCA*PIB PCA Pump Remote Bolus Button Switch

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility