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510(k) Data Aggregation
K Number
K163334Device Name
LiDCOunity v2 Hemodynamic Monitor
Manufacturer
LiDCO Ltd
Date Cleared
2017-06-05
(189 days)
Product Code
DXG, DXN, GWQ
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LiDCO Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare or by personnel trained in its proper use for:
1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with preexisting peripheral arterial line access
5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunty Monitor of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/ Index
Location of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Suites Step Down / High Dependency Units Trauma/Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories
Device Description
Not Found
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K Number
K152935Device Name
LiDCOunity Monitor
Manufacturer
LIDCO LTD
Date Cleared
2016-03-17
(164 days)
Product Code
DXG, GWQ
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index
Device Description
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K Number
K131048Device Name
LIDCO CNAP MODULE
Manufacturer
LIDCO LTD.
Date Cleared
2013-08-28
(135 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals. The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor. The LiDCO CNAP Module supports the following parameters: Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial mean pressure Heart rate Locations of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Sultes Step Down / High Dependency Units Trauma / Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories
Device Description
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K Number
K122247Device Name
LIDCORAPID V2 MONITOR
Manufacturer
LIDCO LTD.
Date Cleared
2013-03-20
(236 days)
Product Code
DXG, GWO
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiDCOrapid V2 Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation
Locations of Use:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
Device Description
Not Found
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K Number
K023960Device Name
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
Manufacturer
LIDCO LTD.
Date Cleared
2003-01-09
(41 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiDCOp/us Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 88lb (40kg) in weight.
SUITABLE PATIENTS:
Patients requiring cardiovascular monitoring who have pre-inserted and venous catheters and preexisting peripheral arterial line access.
LOCATIONS OF USE:
Suitable patients will be receiving treatment in the following areas:
Medical and Surgical Intensive Care Units
Operative Suites
Step Down / High Dependency Units
Trauma / Accident & Emergency Departments
Coronary Intensive Care Units
Cardiac Catheter Laboratories
Device Description
The LiDCOplus Hemodynamic Monitor calculates a number of derived parameters: Body Surface Area, Systolic Pressure Vanation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index.
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K Number
K010049Device Name
PULSECO HEMODYNAMIC MONITOR CM71
Manufacturer
LIDCO LTD.
Date Cleared
2001-06-14
(160 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962918Device Name
LIDCO SYSTEM
Manufacturer
LIDCO LTD.
Date Cleared
1999-01-08
(925 days)
Product Code
DXG
Regulation Number
870.1435Why did this record match?
Applicant Name (Manufacturer) :
LIDCO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTENDED USE: LIDCO SYSTEM for CARDIAC OUTPUT MONITORING
Indications for Use - Diagnostic aid (cardiac output determination). The LiDCO System is intended for the monitoring of cardiac output (blood flow in litres per minute) in patients of greater than 88 lbs (40 kg) in weight.
Device Description
The LIDCo System revisits and improves the indicator dilution technique of cardiac output determination. It avoids the complications of pulmonary artery catheterisation. The LIDCo System will have clinical utility in patients with pre-placed arterial and venous lines, where the determination of cardiac output is required minimally invasively without the insertion of a pulmonary artery catheter.
The lithium cation sensor is biocompatible, thermally compensated and unaffected by changes in arterial blood pressure.
Despite the potential complication of secondary marker recirculation, the LIDCo System software has been demonstrated in a number of bench and clinical studies to calculate the area under the primary indicator dilution curve.
Flow cell moulded from polycarbonate.
Lithium ion selective electrode made from PVC membrane cast onto polyurethane.
Blood contact material PVC - blood not returned to patient.
Monitor CM-31/32: Power supply is by + 5VDC AC to DC Power Supply Unit. Recorder and digital outputs by optical circuits and transformer.
Blood Withdrawal Pump CM-33: Connection with sensor interface is optically isolated. Power supply is by battery operation (6v DC). Low battery warning. Fail safe against arterial blood pressure. "One way" only insertion of pump tubing.
Dimensions & Weight: 320 mm x 260 mm x 40 mm, < 5 lbs.
Display of CO value: Numeric in litres / minute.
Possible to display dilution curve: Yes.
Digital output of CO: Yes - via RS232 port.
Calculation method: Band-Linton derived equation involving area integration of the lithium cation dilution curve with lognormal approach - curve cut at 10% down from peak.
Measurement range: 0.1 to 20 litres / minute.
Self test and/or calibration possible: Yes.
Power source - for power supplied to CO sensor: No power is supplied; not required by LiDCo sensor.
Battery charger/PSU: LiDCo Model CM-34 PSU 115/230 V AC, 50 - 60 hz.
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