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510(k) Data Aggregation
K Number
K092687Device Name
VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
Manufacturer
A PLUS MEDICAL
Date Cleared
2009-11-23
(83 days)
Product Code
NHK
Regulation Number
868.5905Why did this record match?
Product Code :
NHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
Device Description
Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
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K Number
K020281Device Name
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
Manufacturer
VENTLAB CORP.
Date Cleared
2002-02-11
(14 days)
Product Code
NHK
Regulation Number
868.5905Why did this record match?
Product Code :
NHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.
Device Description
Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve
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K Number
K013308Device Name
VENTLAB HYPERINFLATION BAG SYSTEM
Manufacturer
VENTLAB CORP.
Date Cleared
2001-12-20
(77 days)
Product Code
NHK
Regulation Number
868.5905Why did this record match?
Product Code :
NHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.
Device Description
Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.
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K Number
K001714Device Name
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
Manufacturer
MERCURY MEDICAL
Date Cleared
2000-11-03
(151 days)
Product Code
NHK
Regulation Number
868.5905Why did this record match?
Product Code :
NHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970785Device Name
SIMS HYPERINFLATION BAG SYSTEM
Manufacturer
SIMS
Date Cleared
1997-06-13
(101 days)
Product Code
NHK
Regulation Number
868.5905Why did this record match?
Product Code :
NHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffering from respiratory insufficiency. Typical treatment consists of hyperinflating the patient's lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.
Device Description
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis.
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