Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044169

FEI Number

1000283452

Entity Name

PLAXTRON INDUSTRIAL (M) SDN. BHD.

City/State/Country

IPOH Perak, MY

Establishment Address

PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ, IPOH Perak 30020, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PLAXTRON INDUSTRIAL (M) SDN. BHD. (Owner Number: 9005976)

Owner / Operator Contact Address

PLOT 28, KAWASAN PERUSAHAAN, JELAPANG 2, FTZ, IPOH, PERAK, MY-NOTA 30020, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AIRWAY PRESSURE MANOMETER RESUSA-TEE TOOTH PROTECTOR Airway Pressure(Inspiratory Force) METER Flow-Safe CPAP System CPAP EZ-FLOW Anesthesia Mask Anesthesiology Mask CPR BAG (REUSABLE) CPR BAG (DISPOSABLE W/EXPANDABLE RESERVOIR) Oxygen Mask Peep Valve Resistex Expiratory Resistance Exerciser ShurClear DISPOSEAL Disposeal Mouth Piece Hyperinflation (T-Piece Resuscitator) NEO TEE Pump Assembly w/ Private Hand Pump Anesthesia Breathing Circuit MINI STATCO2 CO2 DETECTOR LMA Fastrach¿ SU LMA Unique¿ LMA Flexible¿ SU INTUBATING LARYNGEAL AIRWAY Laryngeal Mask MULTI CONNECTOR ,OMNILINK MALE CONNECTOR DISCONNECT WEDGE EMALE EXTENSION TUBE Nose Clip STATCO2 DETECTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2012-01-17
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2016-04-26
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2006-03-24
BXR	Meter, Airway Pressure (Inspiratory Force)	Anesthesiology	Class 2	868.1780	2007-06-26
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2009-10-28
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-11-10
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-08-27
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-08-26
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2012-01-17
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2012-01-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	1992-08-04
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2012-01-17
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2011-07-21
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2015-02-13
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2011-05-13
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-11-26
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2010-07-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-04-22
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2012-01-17
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-01-17
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2006-09-21
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2006-03-24
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	1992-08-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-01-17

Official Correspondent

JAY WANG

US Agent Details

Jessica LeeChen Email: jessicaleechen@yahoo.com Phone: (734) 6297552

Related Public Records

Same Entity

PLAXTRON INDUSTRIAL (M) SDN. BHD.

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
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044169. Last updated year: 2026. Please use registration number 8044169 when referencing this establishment in official correspondence.