BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pediatric Nasal CPAP Mask Headgear

    Reg #: 3006446479 · FEI: 3006446479 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUNSET HEALTHCARE SOLUTIONS, Inc.
    Registration Number
    3006446479
    FEI Number
    3006446479
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    141 W Jackson Blvd Ste 1950
    City
    CHICAGO
    State
    IL
    ZIP
    60604
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063268

    Owner / Operator

    Firm Name
    Sunset Healthcare Solutions
    Operator Number
    9106379
    Address
    141 West Jackson Boulevard, 1950
    City
    Chicago
    State
    IL
    Postal Code
    60604
    Country
    US
    Correspondent
    JOSEPH - CONSOLI

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Pediatric Nasal CPAP Mask Headgear Pediatric Nasal CPAP Mask Kit with L/XS Adult Cushions Pediatric Full Face CPAP Mask Cushion Replacement Pediatric Nasal CPAP Mask Cushion Replacement Sunset Healthcare CPAP Machine Pediatric Full Face CPAP Mask Headgear Pediatric Nasal CPAP Mask Kit with S/M Cushions Pediatric Full Face CPAP Mask

    Establishment Types

    Repack or Relabel Medical Device