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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2006-08-30 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2020-03-26 |
| Absorbent, Carbon-Dioxide | CBL | Class 1 | Anesthesiology | No | 2007-01-17 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2014-04-17 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2006-08-30 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2018-01-15 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2019-11-19 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2006-08-30 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2026-06-17 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2018-12-10 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2006-08-30 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2007-01-17 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-01-17 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2023-10-27 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2022-01-07 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2026-01-19 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2007-01-18 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2023-07-24 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2017-04-21 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2015-08-12 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2009-06-23 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2006-08-30 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2017-07-25 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2007-01-18 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2009-06-23 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2015-08-12 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-12-17 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2007-01-17 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2006-08-30 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2006-08-30 |
| Urinometer, Mechanical | EXR | Class 2 | Gastroenterology, Urology | No | 2024-02-19 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2007-01-18 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2019-09-20 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2019-02-19 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2006-08-30 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2019-12-19 |
| Incubator, Neonatal Transport | FPL | Class 2 | General Hospital | No | 2017-07-25 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2023-01-19 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2015-01-22 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2006-08-30 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2013-12-03 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-10-24 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2006-08-30 |
| Screw, Oral | KBW | Class 1 | Ear, Nose, Throat | No | 2019-09-20 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2007-01-18 |
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)