Flexicare Medical Dongguan L T D

FDA Filings

This page includes the latest FDA filings for Flexicare Medical Dongguan L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006061749
• FEI Number: 3006061749
• Name: FLEXICARE MEDICAL (DONGGUAN) LTD.
• Owner & Operator: FLEXICARE MEDICAL LTD.
• Contact Address: CYNON VALLEY BUSINESS PARK ; MOUNTAIN ASH GB-RCT Rhondda, Cynon, Taff CF45 4ER GB
• Official Correspondent:
  • Khashayar - Poormand
  • 044-144-474647-x
• US Agent:
  • Ashley Motamedi
  • Flexicare Inc
  • 949 4509999
  • 949 4509992
  • ashley.motamedi@flexicare.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. B-15 XICHENG INDUSTRIAL ZONE HENGLI TOWN,; DONGGUAN CITY Guangdong, 523460 CN
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K191909 | CAH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - STERILE	2020-03-26
PMN K191909 | CAH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE	2020-03-26
PMN K191909 | CAH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	2106570-008 BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE	2020-03-26
PMN K102719 | CAF FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	TriggerNeb Nebulizer	2019-12-19
FOX FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	ProVu Table Stand	2019-11-19
FOX FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	ProVu Pole Stand	2019-11-19
KBW FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Jaw Opener	2019-09-20
CBH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	ET Tube Holder	2019-09-20
ION FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	MEDIFLO RESPIRATORY TRAINER	2019-02-19
PMN K181583 | BTM FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SINGLE USE RESUSCITATOR BAG - PEDIATRIC	2018-12-10
PMN K181583 | BTM FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SINGLE USE RESUSCITATOR BAG - INFANT	2018-12-10
PMN K181583 | BTM FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SINGLE USE RESUSCITATOR BAG - ADULT	2018-12-10
PMN K103833 | BYE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP	2017-07-25
PMN K072021 | BTM FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	NeoPIP Infant Resuscitation Unit	2017-07-25
HTD FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE MAGILL FORCEPS	2017-04-21
PMN K163300 | CAH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	THERMOSHIELD HME FILTER	2017-03-23
PMN K161314 | BTT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE	2016-07-25
PMN K160540 | BZE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE NEONATAL VENTIMYST HEATED WIRE BREATHING SYSTEMS	2016-07-11
PMN K160540 | BZE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS	2016-07-11
PMN K160540 | BTT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE NEONATAL VENTIMYST HEATED WIRE BREATHING SYSTEMS	2016-07-11
PMN K160540 | BTT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS	2016-07-11
GAZ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE	2015-08-12
GAZ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SUCTION TUBES - STERILE	2015-08-12
BTK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE CPAP MASK HEAD STRAP	2015-08-12
PMN K150900 | BZE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Heated Wire Breathing Systems	2015-05-21
PMN K150900 | BZE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE ADULT VENTIMYST HEATED WIRE BREATHING SYSTEMS	2015-05-21
PMN K150900 | BTT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Heated Wire Breathing Systems	2015-05-21
PMN K150900 | BTT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE ADULT VENTIMYST HEATED WIRE BREATHING SYSTEMS	2015-05-21
MNK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	EASYGUARD	2015-01-22
PMN K133516 | CCK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	CO2 monitoring Line	2014-06-11
PMN K133516 | CCK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR	2014-06-11
PMN K140473 | MNK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Dualguard	2014-04-17
PMN K140473 | CCK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Dualguard	2014-04-17
PMN K140473 | CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Dualguard	2014-04-17
PMN K140113 | CCK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Nasal Cannula	2014-04-17
PMN K140113 | CCK FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	CO2 monitoring	2014-04-17
KHA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	SINGLE USE NASAL HOOD (SCENTED & UNSCENTED)	2013-12-03
KHA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	REUSABLE NASAL HOOD (UNSCENTED)	2013-12-03
JRL FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Disc filter	2013-03-21
PMN K092218 | CAH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Breathing Filters	2010-05-12
PMN K091591 | BTR FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare ProVu Video Stylet	2009-06-23
PMN K091591 | BTR FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Endotracheal Tubes	2009-06-23
BSR FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Stylets - Various Sizes	2009-06-23
BSR FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Bougies - Various Sizes	2009-06-23
BSR FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE PROVU VIDEO STYLET	2009-06-23
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	catheter mount 10cm 22F/15F-22M	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	catheter mount 10cm 15M, double swivel, 2 ports	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flextube 15M/15F-22M	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexible Catheter mount 15F/22F	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE CONNECTOR - VARIOUS	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE CATHETER MOUNT - AIRWAY EXTENSION - VARIOUS	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Double Swivel connector 2 ports	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Catheter mount 4 inch 15M/15F-22M	2007-01-18
BZA FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	AIRWAY CONNECTOR	2007-01-18
BYP FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE MOUTHPIECE	2007-01-18
BYH FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE WATER TRAPS	2007-01-18
BYD FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	THERMOTRACH HEAT AND MOISTURE EXCHANGER	2007-01-18
BYD FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	NEONATAL HME CONNECTOR - STERILE	2007-01-18
BYD FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	KING SYSTEMS HME	2007-01-18
BYD FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE TRACHEOSTOMY HME	2007-01-18
CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VEOFLO HIGH FLOW NASAL CANNULA	2007-01-17
CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VEOFLO HIGH FLOW NASAL CANNULA ADAPTER	2007-01-17
CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	NIOFLO OXYGEN CANNULA	2007-01-17
CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE NASAL CANNULA	2007-01-17
CAT FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE HIGH FLOW NASAL CANNULA	2007-01-17
BYX FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE PRESSURE RELIEF VALVE	2007-01-17
BYX FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE OXYGEN TUBING	2007-01-17
BYX FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE APL VALVE	2007-01-17
BSJ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE SILICONE ANAESTHETIC FACE MASKS	2007-01-17
BSJ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE ANAESTHETIC MASKS	2007-01-17
NNZ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Leg Bag Holder Strap	2006-08-30
KGB FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE NON-REBREATHING MASK	2006-08-30
FAQ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	EZ FLOW CATHETER VALVE - STERILE	2006-08-30
EYZ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	EZ-Flow catheter valve	2006-08-30
CCW FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYNGOSCOPES	2006-08-30
CCW FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYNGOSCOPE HANDLES	2006-08-30
CCW FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYNGOSCOPE BLADES	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	breathing circuit pediatric	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	breathing circuit neonatal	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	breathing circuit adult	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE BREATHING CIRCUITS	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Medisize Breathing Circuit Pediatric	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Medisize Breathing Circuit Neonatal	2006-08-30
CAI FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Medisize Breathing Circuit Adult	2006-08-30
CAE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Williams Airway	2006-08-30
CAE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYSEAL PRO LARYNGEAL MASK	2006-08-30
CAE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYSEAL PLUS LARYNGEAL MASK AIRWAY	2006-08-30
CAE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	LARYSEAL LARYNGEAL MASK	2006-08-30
CAE FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	GUEDEL AIRWAY	2006-08-30
BZO FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VEOFLO TRACHEOSTOMY INTERFACE	2006-08-30
BZO FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE CIRCUITS	2006-08-30
BZO FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	Flexicare Breathing Circuit Tubing	2006-08-30
BYG FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE MEDIUM CONCENTRATION MASKS	2006-08-30
BYG FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE FIRST AID MASK	2006-08-30
BYG FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE CPAP MASK HEAD STRAP	2006-08-30
BYG FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	FLEXICARE AEROSOL MASKS	2006-08-30
BYF FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTIMASK VENTURI MASKS	2006-08-30
BYF FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE	2006-08-30
BYF FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE VENTURI MASK	2006-08-30
BTQ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	NasoClear	2006-08-30
BTQ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	NASOSAFE PHARYNGEAL AIRWAY	2006-08-30
BTQ FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	AeroCath	2006-08-30
BTC FLEXICARE MEDICAL (DONGGUAN) LTD. [FLEXICARE MEDICAL LTD.]	VENTICAIRE RESERVOIR BAGS	2006-08-30

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092955310	Yantian,China (Mainland) -> Long Beach, California	MEDICAL DEVICES BRITEBLADE PRO BRITEPRO SOLO NASAL CANNULA HS CODE 901920 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKAGING MATERIALS.	7620 CTN
2020092850359	Yantian,China (Mainland) -> Los Angeles, California	MEDICAL DEVICES HS CODE:901890 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS.	4496 CTN
2020092645495	Yantian,China (Mainland) -> Los Angeles, California	MEDICAL DEVICES HS CODE:901920 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS.	3305 CTN
2020092643317	Yantian,China (Mainland) -> Los Angeles, California	MEDICAL DEVICES HS CODE:901920 901890 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS.	2144 CTN
2020091713637	Yantian,China (Mainland) -> Norfolk, Virginia	MEDICAL DEVICES	1806 CTN
2020091636675	Yantian,China (Mainland) -> Long Beach, California	MEDICAL DEVICES HS CODE:901920 901890 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	2722 CTN
202009168590	Yantian,China (Mainland) -> Los Angeles, California	MEDICAL DEVICES(BRITEBLADE PRO, BRITEPRO SOLO,NASAL CANNULA) HS CODE:901890 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	5787 CTN
2020091614462	Yantian,China (Mainland) -> Norfolk, Virginia	MEDICAL DEVICES	1806 CTN