Plaxtron Industrial M Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Plaxtron Industrial M Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8044169
FEI Number1000283452
NamePLAXTRON INDUSTRIAL (M) SDN. BHD.
Owner & OperatorPLAXTRON INDUSTRIAL (M) SDN. BHD.
Contact AddressPLOT 28, KAWASAN PERUSAHAAN JELAPANG 2, FTZ
IPOH, PERAK MY-NOTA 30020 MY
US Agent
Importing Logistics Registration
ImporterLaerdal Medical Corporation
Address167 Myers Corners Road,P.O. Box 1840 Wappingers Falls
New Hamburg, NY 12590 UNITED STATES
Importer TypeRetailer
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPLOT 28, KAWASAN PERUSAHAAN JELAPANG 2, FTZ
IPOH Perak, 30020 MY
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Air-Q Blocker Tube2020-02-03
PLAXTRON INDUSTRIAL (M) SDN. BHD.
RESUSA-TEE2016-04-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
EZFLOW MAX CONTINUOUS NEBULIZER2016-04-25
PLAXTRON INDUSTRIAL (M) SDN. BHD.
air-Q Tube Holder2016-03-18
PLAXTRON INDUSTRIAL (M) SDN. BHD.
CPAP2015-11-10
PLAXTRON INDUSTRIAL (M) SDN. BHD.
ShurClear2015-02-13
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Pump Assembly w/ Private2014-04-22
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Hand Pump2014-04-22
PLAXTRON INDUSTRIAL (M) SDN. BHD.
LCSU42012-04-19
PLAXTRON INDUSTRIAL (M) SDN. BHD.
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES2012-04-03
PLAXTRON INDUSTRIAL (M) SDN. BHD.
CPR BAG (REUSABLE)2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
CPR BAG (DISPOSABLE W/EXPANDABLE RESERVOIR)2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
AIRWAY PRESSURE MANOMETER2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
CPR BAG ( DISPOSABLE)2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
STATCO2 DETECTOR2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Peep Valve2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
MINI STATCO2 CO2 DETECTOR2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
STATCO2 DETECTOR2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Anesthesia Breathing Circuit2012-01-17
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Resistex2011-07-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Expiratory Resistance Exerciser2011-07-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Disposeal Mouth Piece2011-05-13
PLAXTRON INDUSTRIAL (M) SDN. BHD.
DISPOSEAL2011-05-13
PLAXTRON INDUSTRIAL (M) SDN. BHD.
EZ-FLOW2010-08-27
PLAXTRON INDUSTRIAL (M) SDN. BHD.
OXYGEN TUBING2010-08-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
ANESTHESIA TUBING2010-08-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Anesthesiology Mask2010-08-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Anesthesia Mask2010-08-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
NEO TEE2010-07-23
PLAXTRON INDUSTRIAL (M) SDN. BHD.
(T-Piece Resuscitator)2010-07-23
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Flow-Safe CPAP System2009-10-28
PLAXTRON INDUSTRIAL (M) SDN. BHD.
BACTERIA FILTER2007-11-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Hyperinflation2007-11-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
METER2007-06-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Airway Pressure(Inspiratory Force)2007-06-26
PLAXTRON INDUSTRIAL (M) SDN. BHD.
LMA Unique?2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
LMA Flexible? SU2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
LMA Fastrach? SU2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
INTUBATING LARYNGEAL AIRWAY2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
NASOPHARYNGEAL AIRWAY2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
STYLET BLOCKER AIRWAY2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
BOUGIE2006-09-21
PLAXTRON INDUSTRIAL (M) SDN. BHD.
MULTI CONNECTOR2006-03-24
PLAXTRON INDUSTRIAL (M) SDN. BHD.
EMALE EXTENSION TUBE2006-03-24
PLAXTRON INDUSTRIAL (M) SDN. BHD.
CONNECTOR DISCONNECT WEDGE2006-03-24
PLAXTRON INDUSTRIAL (M) SDN. BHD.
,OMNILINK MALE2006-03-24
PLAXTRON INDUSTRIAL (M) SDN. BHD.
TOOTH PROTECTOR2006-03-24
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Oxygen Mask1992-08-04
PLAXTRON INDUSTRIAL (M) SDN. BHD.
Nose Clip1992-08-04

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092513805Port Swettenham,Malaysia -> Jacksonville, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .825 CTN
2020092517255Port Swettenham,Malaysia -> Los Angeles, CaliforniaMEDICAL APPLIANCES199 CTN
2020091621296Port Swettenham,Malaysia -> Jacksonville, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .863 CTN
2020091221965Port Swettenham,Malaysia -> Jacksonville, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .682 CTN
202009073266Port Swettenham,Malaysia -> Miami, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .687 CTN
2020090320789Port Swettenham,Malaysia -> Jacksonville, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .808 CTN
2020082620725Port Swettenham,Malaysia -> Jacksonville, FloridaRESUSCITATOR UNIT & ITS COMPONENT PARTS . .665 CTN
2020082429556Port Swettenham,Malaysia -> Los Angeles, California(163 BOXES PACKED IN 3 WOODEN PALLETS) 2,356 SUCTION UNIT 4 (LCSU4) P/O NO TN200188163 BOX

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