FDA Registration Active 🇬🇧 United Kingdom

FLEXICARE MEDICAL LTD.

Reg #: 8021995 · FEI: 3006363476 · Expires 2026
Products
48
Proprietary Names
112
Establishment Types
2
Classifications
48

Registration Details

Registration Name
FLEXICARE MEDICAL LTD.
Registration Number
8021995
FEI Number
3006363476
Status
Active
Expiry Year
2026
Initial Importer
No
Address
CYNON VALLEY BUSINESS PARK, MOUNTAIN ASH
City
RHONDDA CYNON TAFF Wales
Country
GB

Regulatory Submissions

510(k) Number
K191909

Owner / Operator

Firm Name
FLEXICARE MEDICAL LTD.
Operator Number
8021995
Address
CYNON VALLEY BUSINESS PARK
City
MOUNTAIN ASH
State
Rhondda Cynon Taff
Postal Code
CF45 4ER
Country
GB
Correspondent
Rebecca - Funston

Products

Device Name Product Code
Mask, Oxygen, Low Concentration, Venturi BYF
Filter, Bacterial, Breathing-Circuit CAH
Absorbent, Carbon-Dioxide CBL
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Mask, Oxygen, Non-Rebreathing KGB
Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
Stand, Infusion FOX
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Ventilator, Emergency, Manual (Resuscitator) BTM
Mask, Oxygen BYG
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Cannula, Nasal, Oxygen CAT
Tubing, Pressure And Accessories BYX
Clip, Nose BXJ
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
Mouthpiece, Breathing BYP
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Percussor, Powered-Electric BYI
Unit, Filter, Membrane JRL
Forceps HTD
Strap, Head, Gas Mask BTK
Stylet, Tracheal Tube BSR
Bag, Reservoir BTC
Attachment, Breathing, Positive End Expiratory Pressure BYE
Drain, Tee (Water Trap) BYH
Tube, Tracheal (W/Wo Connector) BTR
Tubing, Noninvasive GAZ
Catheter And Tip, Suction JOL
Mask, Gas, Anesthetic BSJ
Laryngoscope, Rigid CCW
Airway, Nasopharyngeal BTQ
Urinometer, Mechanical EXR
Connector, Airway (Extension) BZA
Device, Fixation, Tracheal Tube CBH
Exerciser, Non-Measuring ION
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
Nebulizer (Direct Patient Interface) CAF
Incubator, Neonatal Transport FPL
Catheters, Suction, Tracheobronchial BSY
Endoscopic Bite Block MNK
Airway, Oropharyngeal, Anesthesiology CAE
Mask, Scavenging KHA
Clamp HXD
Set, Tubing And Support, Ventilator (W Harness) BZO
Screw, Oral KBW
Condenser, Heat And Moisture (Artificial Nose) BYD

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 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 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 clic Closed Suction Catheter EASYGUARD GUEDEL AIRWAY LARYSEAL PLUS LARYNGEAL MASK AIRWAY LARYSEAL PRO LARYNGEAL MASK Williams Airway LARYSEAL LARYNGEAL MASK REUSABLE NASAL HOOD (UNSCENTED) SINGLE USE NASAL HOOD (SCENTED & UNSCENTED) ProVu FlexiArm VEOFLO TRACHEOSTOMY INTERFACE Flexicare Breathing Circuit Tubing VENTICAIRE CIRCUITS Jaw Opener FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMS FLEXICARE NEONATAL VENTIMYST HEATED WIRE BREATHING SYSTEMS FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE THERMOTRACH HEAT AND MOISTURE EXCHANGER NEONATAL HME CONNECTOR - STERILE FLEXICARE TRACHEOSTOMY HME NeoPIP Infant Resuscitation Unit Dualguard

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)