BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Comfort Gel Blue Nasal Mask

    Reg #: 3027553886 · FEI: 3027553886 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Respironics, Inc.
    Registration Number
    3027553886
    FEI Number
    3027553886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Coyol Free Zone and Business Park, Building B37
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K092835

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Tom Fallon
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

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

    Proprietary Names

    Comfort Gel Blue Nasal Mask

    Establishment Types

    Manufacture Medical Device