BEUDAMED
    FDA Registration Active 🇺🇸 United States

    REDSTONE HEALTHCARE LLC

    Reg #: 3010952312 · FEI: 3010952312 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    REDSTONE HEALTHCARE LLC
    Registration Number
    3010952312
    FEI Number
    3010952312
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    825 S Waukegan Road, A8 #161
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K134016

    Owner / Operator

    Firm Name
    Redstone Healthcare LLC
    Operator Number
    10048374
    Address
    825 S Waukegan Road, A8 #161
    City
    Lake Forest
    State
    IL
    Postal Code
    60045
    Country
    US
    Correspondent
    Keith Rubenstein

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    Catheter, Ultrasound, Intravascular OBJ
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND EPIQ Cvx and Series Diagnostic Ultrasound System; Affiniti Cvx and Series Diagnostic Ultrasound System

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198