BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NUO THERAPEUTICS, INC.

    Reg #: 3004140833 · FEI: 3004140833 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    NUO THERAPEUTICS, INC.
    Registration Number
    3004140833
    FEI Number
    3004140833
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8285 El Rio, Suite 190
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK060007

    Owner / Operator

    Firm Name
    Nuo Therapeutics, Inc.
    Operator Number
    9058053
    Address
    8285 El Rio, Suite 190
    City
    Houston
    State
    TX
    Postal Code
    77054
    Country
    US
    Correspondent
    Peter Clausen

    Products

    Device Name Product Code
    Phlebotomy Blood Collection Kit OFM
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Aurix XL Aurix 4TR Aurix Multifly 4-Pack

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device