BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Comfort Gel Blue Nasal Mask

    Reg #: 3002797442 · FEI: 3002797442 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RESPIRONICS, INC.
    Registration Number
    3002797442
    FEI Number
    3002797442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    174 Tech Center Drive
    City
    Mount Pleasant
    State
    PA
    ZIP
    15666
    Country
    US

    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

    Products

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

    Proprietary Names

    Comfort Gel Blue Nasal Mask

    Establishment Types

    Repack or Relabel Medical Device