RESMED PTY LTD.

FDA Device Registration & Listing · BELLA VISTA New South Wales, AU · Registration 3004604967

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004604967
FEI Number
3004604967
Entity Name
RESMED PTY LTD.
City/State/Country
BELLA VISTA New South Wales, AU
Establishment Address
1 ELIZABETH MACARTHUR DRIVE, BELLA VISTA New South Wales 2153, AU
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
RESMED CORP. (Owner Number: 9002319)
Owner / Operator Contact Address
9001 Spectrum Center Blvd, --, San Diego, CA 92123, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Air tubing connector SULLIVAN NASAL CPAP SYSTEM AirFit F20 F20 QuietAir Elbow S8 CPAP System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2016-09-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-04-20
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2013-03-24
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-04-29
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2014-04-14
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2014-05-27
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2014-05-27
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2014-05-27
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-05-27
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-06-18
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2026-03-17
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-03-17
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2014-12-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-04-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2016-04-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-09-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2019-05-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-11-05
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-07-26
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2010-01-05
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-08-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-06-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-04-02
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-11-10
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2020-11-10
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2014-06-05
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2014-06-05
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-06-10
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2015-01-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-05-13
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2014-05-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-08-04
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2016-07-18
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2016-07-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2021-01-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-02-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-03-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2019-05-22
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2011-01-30
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2026-03-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-05-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BRY Cabinet, Table And Tray, Anesthesia Anesthesiology Class 1 868.6100 2010-02-21
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2014-01-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-01-06
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-07-07
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2013-03-17
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2012-02-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-12-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2023-06-01
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2007-01-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-15
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-03-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2015-07-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-07-28

Official Correspondent

David Lanfranchi

US Agent Details

David Lanfranchi Business: ResMed Corp Email: RegulatoryTeam-Americas@ResMed.com Phone: (858) 8365000

Related Public Records

Same Entity

RESMED CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017684630 ResMed Asia Pte. Ltd. Singapore South West, SG
3011205710 ResMed Corp Lithia Spgs, GA, US
3007009701 ResMed West Coast Warehouse Moreno Valley, CA, US
3007573469 RESMED CORP San Diego, CA, US
3038236812 ResMed Malaysia Operations Sdn Bhd Senai Johor, 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
K033276 Resmed, Ltd. VPAP III ST-A 2004-06-07
K051895 Datex-Ohmeda, Inc. GE DATEX-OHMEDA ENGSTROM CARESTATION 2005-09-27

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-0008-2015 Respironics California Inc 2
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.

Similar Registrations

Registration Number Establishment Name Location
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3014301596 VINCENT REHAB DEVICES COMPANY LIMITED HONGKONG, HK
3007573469 RESMED CORP San Diego, CA, US
3003431869 HILBRO INTERNATIONAL (PVT) LIMITED SIALKOT Punjab, PK
3010889742 SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD SHAOXING Zhejiang, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004604967. Last updated year: 2026. Please use registration number 3004604967 when referencing this establishment in official correspondence.
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