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510(k) Data Aggregation

    K Number
    K250243
    Device Name
    ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
    Date Cleared
    2025-05-20

    (113 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flexicare Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ProVu Endotracheal Tube with Video Stylet is intended for intubation procedures. The ProVu Endotracheal Tube with Video Stylet is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations. The ProVu Endotracheal Tube with Video Stylet is indicated for viewing during non-difficult and difficult intubation procedures and for verifying endotracheal tube placement.
    Device Description
    The ProVu Video Stylet with Reinforced ET Tube is a sterile, single-use, video-enabled stylet and ETT intubation system with malleable and directional control intended to assist with oral and nasal intubations and designed for use in adults in a hospital environment. The device comprises of two main components: - The ProVu Reinforced Endotracheal tube - The ProVu Video Stylet (with a removable malleable rod)
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    K Number
    K201666
    Device Name
    SINGLE USE MANOMETER
    Date Cleared
    2020-11-13

    (147 days)

    Product Code
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flexicare Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
    Device Description
    Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
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    K Number
    K191909
    Device Name
    HepaShield Bacterial Viral Breathing System Filter
    Date Cleared
    2020-03-23

    (250 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flexicare Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
    Device Description
    Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use. The patient side of the Flexicare's HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical. All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard. Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes. Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
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    K Number
    K181583
    Device Name
    Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
    Date Cleared
    2018-12-07

    (175 days)

    Product Code
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flexicare Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments. Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments. Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
    Device Description
    Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required. Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve. Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
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    K Number
    K163300
    Device Name
    ThermoShield HME Filter
    Date Cleared
    2017-03-22

    (120 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flexicare Medical Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device. Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes. Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel. Expert clinical judgment must be used in assessing patient humidification requirements.
    Device Description
    Flexicare's ThermoShield HME Filters are designed to prevent the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration Flexicare's ThermoShield HME Filters include a HME (Heat and Moisture Exchanger) Media in addition to a filter. The Inclusion of HME media is intended to help prevent complications due to drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT) occlusion. This is achieved by the HME media preventing a large amount of the water vapor from passing through the device. Flexicare's ThermoShield HME Filters consist of a top/bottom housing, filter pad, HME media and a luer port cap. The Female luer-lock port allows monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use. The patient side of the Flexicare's ThermoShield HME Filters feature a 22mm Male and a 15mm Female conical connector. The machine side features a 22mm Female and a 15mm Male conical connector. All conical connectors comply with dimensions stated within BS EN ISO 5356-1: 2004 Flexicare's ThermoShield HME Fitters have rounded housing with no sharp edges. This reduces the risk of pressure marks on the patient. Flexicare's ThermoShield HME Fitters are available in Adult and Mini (Pediatric) sizes. Flexicare's ThermoShield HME Filters are supplied non sterile in individually sealed polybags.
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    K Number
    K161314
    Device Name
    FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
    Date Cleared
    2016-07-06

    (56 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXICARE MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flexicare FL-9000U Respiratory Humidifier Base is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used only with the Flexicare Heated Wire Breathing System and Flexicare Autofill Humidification Chamber.
    Device Description
    The Flexicare FL-9000U Respiratory Humidifier Base is for use as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated adult patients and those receiving respiratory support, as part of a complete system including a Humidification Chamber and either a heated wire breathing circuit or limb, or a non-heated breathing circuit or limb. The Flexicare FL-9000U Respiratory Humidifier Base is a non-sterile medical electrical device which when in use forms part of an actively humidified respiratory humidification system. The Flexicare FL-9000U features a heater plate that allows a humidification chamber containing a volume of water to secure in place above it. The Flexicare FL-9000U heats the water within a humidification chamber and provides current to heated wires within Heated Wire Breathing System (if using a heated system) to warm and humidify gases to be administered to the patient. The Flexicare FL-9000U Respiratory Humidifier Base is provided with temperature probe leads that connect to the patient end and humidification chamber end of a breathing system. These probes feedback to the FL-9000U which automatically adjusts heat and current accordingly to maintain the set gas temperature. When in use the Flexicare FL-9000U Respiratory Humidifier Base has no contact with the patient. The probe tip of the temperature probe lead accessory contacts breathing gases that are to be delivered to the patient and is the only component of the device/its accessories with contact of this nature. The Flexicare FL-9000U Respiratory Humidifier Base is mains powered (115V), intended for use within a hospital environment and intended for any patient population where active humidification is required.
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    K Number
    K160540
    Device Name
    FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
    Date Cleared
    2016-06-23

    (118 days)

    Product Code
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXICARE MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare Neonatal Heated Wire Breathing Systems are intented for use to connect a patient's arway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min. Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
    Device Description
    Flexicare Neonatal Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient. Flexicare Neonatal Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidification Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source. The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient. The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System. Flexicare's Neonatal Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Neonatal patients.
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    K Number
    K150900
    Device Name
    Flexicare Heated Wire Breathing Systems
    Date Cleared
    2015-05-15

    (42 days)

    Product Code
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXICARE MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size. Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
    Device Description
    Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient. Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source. The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient. The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System. Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.
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    K Number
    K133516
    Device Name
    CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
    Manufacturer
    Date Cleared
    2014-04-30

    (166 days)

    Product Code
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXICARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
    Device Description
    Flexicare's CO2 monitoring line is single patient use, small diameter tubing intended to be connected to a luer lock connector on a patient interface to allow for gas sampling from a patients exhaled breath by gas sampling equipment. The Gas monitoring/analysing device will feature a pump, which draws expired breath from the patient through the monitoring line and into the gas analyser. Flexicare's CO2 monitoring line is available with or without a 0.45um hydrophobic filter, which prevents the transfer of water vapour down the monitoring line and into the gas sampling equipment. Flexicare's CO2 monitoring lines feature clear construction to aid visual inspection of the device. The CO2 monitoring line is a single patient use device, designed for use with one patient over a single course of treatment. The CO2 monitoring line is supplied in a sealed poly bag in a non sterile state and is not to be sterilized. The Flexicare CO2 monitoring lines feature 2M & 3M length tubes.
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    K Number
    K140473
    Device Name
    DUALGUARD
    Date Cleared
    2014-04-10

    (44 days)

    Product Code
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXICARE MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery. The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.
    Device Description
    DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure. DualGuard™ consists of a bite block with a removable oxygen delivering/ CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth. When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2. DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit. The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading. DualGuard™ is available in adult size only.
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