Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1832562

FEI Number

1832562

Entity Name

Pulmodyne Inc.

City/State/Country

Indianapolis, IN, US

Establishment Address

2055 Executive Dr, Indianapolis, IN 46241, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ENGINEERED MEDICAL SYSTEMS (Owner Number: 9022693)

Owner / Operator Contact Address

2055 EXECUTIVE DR., --, INDIANAPOLIS, IN 46241, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SealFlex BiTrac BiTrac HC BiTrac Select Control Cric BVM Strap Silicone Adapter - eValueMed BiTrac 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 BiTrac SealFlex BiTrac HC Profit BiTrac Select Aero-Sat Aero-T+ Aero-T

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2016-01-11
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2021-02-12
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2013-01-15
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2025-04-10
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2024-09-09
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2021-10-25
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2007-12-04
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-12-09
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2007-12-04
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-12-04
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-12-04
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2020-12-08
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-08-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-04
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2018-06-19

Official Correspondent

TAMARA LEFEVERS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENGINEERED MEDICAL SYSTEMS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011503227	Intersurgical Medical Sdn. Bhd.	Simpang Ampat Pulau Pinang, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1832562. Last updated year: 2026. Please use registration number 1832562 when referencing this establishment in official correspondence.