Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017684630

FEI Number

3017684630

Entity Name

ResMed Asia Pte. Ltd.

City/State/Country

Singapore South West, SG

Establishment Address

3 Tuas Avenue 2, Singapore South West 639443, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RESMED CORP. (Owner Number: 9002319)

Owner / Operator Contact Address

9001 Spectrum Center Blvd, --, San Diego, CA 92123, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nightowl

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	2018-07-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2009-11-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-08-21
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2023-02-22
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-04-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-03-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-11-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2009-06-10
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-01-25
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2016-04-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-08-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-04-08
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2021-01-12
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2004-06-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2022-03-23
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-03-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2019-05-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-02-09
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-05-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-05-15
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-09-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2016-11-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-04-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2014-06-18
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2023-06-01

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
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
3030970580	RMO	Johor Bahru, 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
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

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-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017684630. Last updated year: 2026. Please use registration number 3017684630 when referencing this establishment in official correspondence.