Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003496134

FEI Number

3003496134

Entity Name

AIRWAY MANAGEMENT INC.

City/State/Country

Farmers Branch, TX, US

Establishment Address

4300 Alpha Road, SUITE 115, Farmers Branch, TX 75244, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIRWAY MANAGEMENT INC. (Owner Number: 9059181)

Owner / Operator Contact Address

4300 Alpha Road, Suite, SUITE 115, Farmers Branch, TX 75244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nylon flexTAP THERMOBLEND AM Aligner TAP T TAP I myTAP PAP Nasal Pillow Mask TAP III dreamTAP TAP 3 Elite BITE REGISTRATION; TAP GAUGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-12-05
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2004-08-03
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2010-01-26
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2003-10-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-11-07
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2003-10-17
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2015-05-27
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2011-03-08

Official Correspondent

Eric Jarrett

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AIRWAY MANAGEMENT INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
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

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

Similar Registrations

Registration Number	Establishment Name	Location
3030914478	GELB PRACTICE	Dix Hills, NY, US
3017092365	APNOMED, INC.	Bellevue, WA, US
3039643908	EMA-SLEEP INC	Bastrop, TX, US
3007108578	TRUE FUNCTION LABORATORY INC	La Mesa, CA, US
3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003496134. Last updated year: 2026. Please use registration number 3003496134 when referencing this establishment in official correspondence.