BEUDAMED
    FDA Registration Active 🇺🇸 United States

    U072323M0X1A4

    Reg #: 1832562 · FEI: 1832562 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Pulmodyne Inc.
    Registration Number
    1832562
    FEI Number
    1832562
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2055 Executive Dr
    City
    Indianapolis
    State
    IN
    ZIP
    46241
    Country
    US

    Owner / Operator

    Firm Name
    ENGINEERED MEDICAL SYSTEMS
    Operator Number
    9022693
    Address
    2055 EXECUTIVE DR., --
    City
    INDIANAPOLIS
    State
    IN
    Postal Code
    46241
    Country
    US
    Correspondent
    TAMARA - LEFEVERS

    Products

    Device Name Product Code
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP

    Proprietary Names

    U072323M0X1A4 15156000 C120323M0X1E5 72946000 F060323M0X1E5 15166000 PC12123M90000 B0028000 19416500 C120323M0X1C5 U060323M1X1E4 J0004001 2158009 M5704000 F060323M3X1E4 U096323M0X1A4 C120323M1X1E5 D72M317M1X1A4 M5782002 D072323M0X1A4 A0066000 U072323M0X1E5 M5974000 C120323M0X1A4 B0031000 D120323M1X1A4 F96M317M0X1A4 D072323M2X1E4 U072323M0X100 D12M317M1X1A4 2158010 PC12113M0X500

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)