Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006061749

FEI Number

3006061749

Entity Name

FLEXICARE MEDICAL (DONGGUAN) LTD.

City/State/Country

DONGGUAN CITY Guangdong, CN

Establishment Address

No. B-15 XICHENG INDUSTRIAL ZONE, HENGLI TOWN,, DONGGUAN CITY Guangdong 523460, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FLEXICARE MEDICAL LTD. (Owner Number: 8021995)

Owner / Operator Contact Address

CYNON VALLEY BUSINESS PARK, MOUNTAIN ASH, GB-RCT CF45 4ER, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ProVu FlexiArm ET Tube Holder Nasal Cannula CO2 monitoring Flexicare Connector Flexible Catheter Mount Kingsystems FLEXICARE MOUTHPIECE ONE WAY VALVE EXP(200) ONE WAY VALVE INSP (500) ONE WAY VALVE:INSP (5X20) ONE WAY VALVE INSP (200) ONE WAY VALVE:EXP (5X20) Urimeter Flexicare Breathing Filters InspiraChamber, VentiChamber Jaw Opener FLEXICARE AEROSOL MASKS FLEXICARE CPAP MASK HEAD STRAP FLEXICARE FIRST AID MASK VENTICAIRE MEDIUM CONCENTRATION MASKS FLEXICARE SILICONE ANAESTHETIC FACE MASKS FLEXICARE ANAESTHETIC MASKS SootherMask InspiraMask ProVu Endotracheal Tube with Video Stylet NasoClear NASOSAFE PHARYNGEAL AIRWAY EZ FLOW CATHETER VALVE - STERILE VENTICAIRE NON-REBREATHING MASK FL-10000U Respiratory Humidifier FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS FLEXICARE NEONATAL VENTIMYST HEATED WIRE BREATHING SYSTEMS Flexicare High Flow Nasal Cannula Veoflo High Flow Nasal Cannula Nioflo Oxygen Cannula Flexicare Nasal Cannula Veoflo Pro High Flow Nasal Cannula BritePro Omni ProVu Video Laryngoscope BriteBlade Pro BritePro Solo ProVu Lite Kingsystems Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP 2106570-008 BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - STERILE Leg Bag Holder Strap Hygrovent Gold FLEXICARE CPAP MASK HEAD STRAP Disc filter FLEXICARE PRESSURE RELIEF VALVE FLEXICARE APL VALVE FLEXICARE OXYGEN TUBING MEDIFLO RESPIRATORY TRAINER Hygrovent Gold Heater and Booster T-Piece Flexicare Endotracheal Tubes VentiSeal Endotracheal Tubes MAXINEB DUO NEBULIZER VEOFLO TRACHEOSTOMY INTERFACE Flexicare Breathing Circuit Tubing VENTICAIRE CIRCUITS EZ-Flow catheter valve EASYGUARD Barr-Vent Hygrovent CO2 monitoring Line CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR FLEXICARE MAGILL FORCEPS FLEXICARE WATER TRAPS THERMOSHIELD HME FILTER REUSABLE NASAL HOOD (UNSCENTED) SINGLE USE NASAL HOOD (SCENTED & UNSCENTED) clic Closed Suction Catheter FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE FLEXICARE SUCTION TUBES - STERILE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2023-10-24
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2019-09-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-04-17
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2007-01-18
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2007-01-18
EXR	Urinometer, Mechanical	Gastroenterology, Urology	Class 2	876.1800	2024-02-19
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2010-05-12
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2023-10-12
KBW	Screw, Oral	Ear, Nose, Throat	Class 1	874.4420	2019-09-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2006-08-30
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2007-01-17
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-05-21
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2025-05-21
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2006-08-30
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-08-30
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2006-08-30
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2026-01-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-01-19
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2016-07-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2016-07-11
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-01-17
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2006-08-30
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2018-01-15
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2017-07-25
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2020-03-26
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-08-30
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2018-01-15
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2015-08-12
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2013-03-21
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-01-17
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2019-02-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2018-01-15
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2009-06-23
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2019-12-19
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2006-08-30
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-08-30
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2015-01-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2018-01-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2014-06-11
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-04-21
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2007-01-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2017-03-23
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2013-12-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2023-01-19
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2015-08-12

Official Correspondent

Rebecca Funston

US Agent Details

ASHLEY MOTAMEDI Email: ashley.motamedi@flexicare.com Phone: (949) 4509999

Related Public Records

Same Entity

FLEXICARE MEDICAL LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
9610639	CLEMENT CLARKE INTL., LTD.	Mountain Ash Rhondda Cynon Taff, GB
3017202422	Flexicare Lanka (Pvt) Ltd	Bandaragama Western, LK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006061749. Last updated year: 2026. Please use registration number 3006061749 when referencing this establishment in official correspondence.