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510(k) Data Aggregation
K Number
K150900Device Name
Flexicare Heated Wire Breathing Systems
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2015-05-15
(42 days)
Product Code
BZE, BTT
Regulation Number
868.5270Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K140473Device Name
DUALGUARD
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2014-04-10
(44 days)
Product Code
CCK, CAT, MNK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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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K Number
K140113Device Name
O2 NASAL CANNULA WITH CO2 MONITORING
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2014-03-06
(50 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring
Device Description
O2 Nasal cannula with CO2 monitoring that is intended to situate under the patients nose with the prongs of the cannula inserted into patients nostrils where oxygen is administered and CO2 monitored. The O2 Nasal cannula with CO2 monitoring has two co-extruded tubes
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K Number
K132619Device Name
CLASSIC INTERMITTENT CATHETER
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2013-10-11
(51 days)
Product Code
EZD, MAN
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Classic™ intermittent catheters are intended for use in Mate, Female and Paediatic patients when regular assisted bladder drainage has been instructed by a physician. Classic™ intermittent catheters are indicated for use by individuals whose ablity to void the bladder fully by natural bodily functions is impaired.
Device Description
Classic ™ Intermittent Catheter is a PVC plastic device that is intended to be inserted through urethra and into bladder of patient to allow drainage of urine. The Classic Intermittent catheter in pouch consists of a tube which is bonded onto a drainage funnel. Classic™ Intermittent Catheter has a round polished finish tip to provide maximum comfort for user. Each catheter features two large evelets in order to drain urine efficiently. Drainage eyelets cut-outs are smooth and rounded to minimize the risk of injury/discomfort when in use. Classic ™ Intermittent Catheters are available in: Adult Male. Available in coude tip or straight tip Adult Female. Available in straight tip Paediatic. Available in straight tip
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K Number
K092218Device Name
FLEXICARE BREATHING FILTERS
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2009-10-06
(76 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anaesthesia machines and open flow systems where filtration of inspired and expired gases is required. The filter may be located at the machine end of expiratory and/or inspiratory limb of the circuit or at the patient end of the circuit Single patient use up to 24 hours.
Device Description
Breathing Filters Bacterial
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K Number
K091591Device Name
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
Manufacturer
FLEXICARE MEDICAL LTD.
Date Cleared
2009-06-17
(15 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
FLEXICARE MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.
Device Description
The Flexicare Endotracheal tube is a single lumen tube with or without a cuff. The device is used for airway management / gas transport and is connected to a ventilator or resuscitation devices via a connector and breathing tubing. Cuffed variants have an inflatable Cuff, a narrow inflation lumen and pilot balloon with valve permitting inflation and deflation using a suitable syringe fitted with a tapered luer connector. All variants (less reinforced) have a radio opaque marker consisting of an axial line embedded into the tube which enables identification the device when patient is x-ray viewed. All variants have a Murphy eye. All variants are supplied sterile and are single use/disposable.
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