FLEXICARE MEDICAL LTD.

FDA Device Registration & Listing · RHONDDA CYNON TAFF Wales, GB · Registration 8021995

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8021995
FEI Number
3006363476
Entity Name
FLEXICARE MEDICAL LTD.
City/State/Country
RHONDDA CYNON TAFF Wales, GB
Establishment Address
CYNON VALLEY BUSINESS PARK, MOUNTAIN ASH, RHONDDA CYNON TAFF Wales CF45 4ER, GB
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

VENTICAIRE VENTURI MASK VENTIMASK VENTURI MASKS VENTICAIRE 2106570-008 BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - NON-STERILE HEPASHIELD BACTERIAL VIRAL BREATHING SYSTEM FILTER - STERILE VENTISORB Nasal Cannula CO2 monitoring VENTICAIRE NON-REBREATHING MASK Hygrovent Gold Heater and Booster T-Piece Hygrovent Barr-Vent ProVu Pole Stand ProVu Table Stand CO2 monitoring Line CAPNOCARE MONITORING LINE WITH CONICAL CONNECTOR Medisize Breathing Circuit Adult breathing circuit pediatric Medisize Breathing Circuit Pediatric breathing circuit adult Medisize Breathing Circuit Neonatal breathing circuit neonatal VENTICAIRE BREATHING CIRCUITS ProVu Vista Tower, ProVu Vista Accessories FLEXICARE SINGLE USE RESUSCITATOR BAG - INFANT FLEXICARE SINGLE USE RESUSCITATOR BAG - PEDIATRIC FLEXICARE SINGLE USE RESUSCITATOR BAG - ADULT FLEXICARE AEROSOL MASKS FLEXICARE CPAP MASK HEAD STRAP FLEXICARE FIRST AID MASK VENTICAIRE MEDIUM CONCENTRATION MASKS Kingsystems EZ FLOW CATHETER VALVE - STERILE Flexicare High Flow Nasal Cannula Veoflo High Flow Nasal Cannula Nioflo Oxygen Cannula Flexicare Nasal Cannula Veoflo Pro High Flow Nasal Cannula FLEXICARE PRESSURE RELIEF VALVE FLEXICARE APL VALVE FLEXICARE OXYGEN TUBING Nose Clip Single Use Manometer for Flexicare Single Use Resuscitator Bag FL-10000U Respiratory Humidifier Hygrovent Gold 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) Flexicare Heated Wire Breathing Systems FLEXICARE ADULT VENTIMYST HEATED WIRE BREATHING SYSTEMS EZ-Flow catheter valve Flutter Disc filter FLEXICARE MAGILL FORCEPS FLEXICARE CPAP MASK HEAD STRAP Flexicare Bougies - Various Sizes Flexicare Stylets - Various Sizes VENTICAIRE RESERVOIR BAGS Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP FLEXICARE WATER TRAPS Flexicare Endotracheal Tubes VentiSeal Endotracheal Tubes FLEXICARE SUCTION TUBING, CONTINUOUS COIL - NON STERILE FLEXICARE SUCTION TUBES - STERILE Flexicare Closed Suction Catheter FLEXICARE SILICONE ANAESTHETIC FACE MASKS FLEXICARE ANAESTHETIC MASKS SootherMask InspiraMask THERMOSHIELD HME FILTER BritePro Omni ProVu Video Laryngoscope BriteBlade Pro BritePro Solo ProVu Lite ProVu Endotracheal Tube with Video Stylet NasoClear NASOSAFE PHARYNGEAL AIRWAY Urimeter Flexicare Connector Flexible Catheter Mount Kingsystems ET Tube Holder MEDIFLO RESPIRATORY TRAINER Leg Bag Holder Strap MAXINEB DUO NEBULIZER Flexicare Breathing Filters NeoForce Skin Temperature Probe, Disposable; NeoForce Skin Temperature Probe, Reusable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2006-08-30
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2020-03-26
CBL Absorbent, Carbon-Dioxide Anesthesiology Class 1 868.5300 2007-01-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2014-04-17
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2006-08-30
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2018-01-15
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2018-01-15
FOX Stand, Infusion General Hospital Class 1 880.6990 2019-11-19
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2014-06-11
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2006-08-30
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2026-06-17
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2018-12-10
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2006-08-30
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2018-01-15
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2006-08-30
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2007-01-17
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2007-01-17
BXJ Clip, Nose Anesthesiology Class 1 868.6225 2023-10-27
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2022-01-07
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
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2018-01-15
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2007-01-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2015-05-21
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2015-05-21
EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile Gastroenterology, Urology Class 1 876.5250 2006-08-30
BYI Percussor, Powered-Electric Anesthesiology Class 2 868.5665 2023-07-24
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2013-03-21
HTD Forceps General, Plastic Surgery Class 1 878.4800 2017-04-21
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2015-08-12
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2009-06-23
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2006-08-30
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2017-07-25
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2007-01-18
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2009-06-23
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2015-08-12
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2021-12-17
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2007-01-17
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2017-03-23
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2006-08-30
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
EXR Urinometer, Mechanical Gastroenterology, Urology Class 2 876.1800 2024-02-19
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2007-01-18
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2019-09-20
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2019-02-19
NNZ System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2006-08-30
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2019-12-19
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2010-05-12
FPL Incubator, Neonatal Transport General Hospital Class 2 880.5410 2017-07-25

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
3006061749 FLEXICARE MEDICAL (DONGGUAN) LTD. DONGGUAN CITY Guangdong, CN
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
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26
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
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28

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 8021995. Last updated year: 2026. Please use registration number 8021995 when referencing this establishment in official correspondence.
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