BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pulmodyne Inc.

    Reg #: 1832562 · FEI: 1832562 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    68
    Establishment Types
    4
    Classifications
    20

    Registration Details

    Registration Name
    Pulmodyne Inc.
    Registration Number
    1832562
    FEI Number
    1832562
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2055 Executive Dr
    City
    Indianapolis
    State
    IN
    ZIP
    46241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972605

    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
    Ventilator, Non-Continuous (Respirator) BZD
    Tube, Tracheostomy (W/Wo Connector) BTO
    Strap, Head, Gas Mask BTK
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Connector, Airway (Extension) BZA
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Exerciser, Non-Measuring ION
    Spirometer, Diagnostic BZG
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Filter, Bacterial, Breathing-Circuit CAH
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Nebulizer (Direct Patient Interface) CAF
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Applicator (Laryngo-Tracheal), Topical Anesthesia CCT
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Airway, Oropharyngeal, Anesthesiology CAE
    Percussor, Powered-Electric BYI
    Mask, Gas, Anesthetic BSJ

    Proprietary Names

    SealFlex BiTrac BiTrac HC BiTrac Select Control Cric BVM Strap Silicone Adapter - eValueMed Valved T 29026000 21516000 91236000 PC12113M0X500 19426500 U096323M0X1A4 15156000 U072323M0X1E5 C120323M0X1C5 15606500 J0004001 M5704000 B0031000 C120323M0X1E5 72946000 C120323M1X1E5 U060323M1X1E4 F060323M0X1E5 D072323M2X1E4 D072323M0X1A4 U072323M0X100 2158009 D12M317M1X1A4 C120323M0X1A4 15166000 M5974000 D120323M1X1A4 F96M317M0X1A4 19416500 2158010 M5782002 PC12123M90000 A0066000 B0028000 F060323M3X1E4 U072323M0X1A4 D72M317M1X1A4 Breathe+ Pulmonary Function Filter O2-MAX O2 Resq AccuPAP Go-PAP DPM VentiSure2 FENEM VT Select eValueMed DART EZ-Spray Continuous Care Profit Aero-Sat Aero-T+ Aero-T APV DART-REACH 8004032 Percussor COBRA PLA

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device