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Found 7 results
510(k) Data Aggregation
K Number
K112852Device Name
BABI PLUS NEONATAL RESUSCITATION BAG
Manufacturer
A PLUS MEDICAL
Date Cleared
2012-01-13
(87 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
Device Description
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
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K Number
K110471Device Name
BABI PLUS INFANT NASAL CANNULA SYSTEM
Manufacturer
A PLUS MEDICAL
Date Cleared
2011-10-07
(231 days)
Product Code
BZD, C10
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.
Device Description
Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.
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K Number
K110383Device Name
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
Manufacturer
A PLUS MEDICAL
Date Cleared
2011-08-01
(172 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.
Device Description
The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.
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K Number
K102377Device Name
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
Manufacturer
A PLUS MEDICAL
Date Cleared
2010-11-18
(90 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.
Device Description
Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.
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K Number
K093716Device Name
BABI PLUS INFANT NASAL CANNULA SYSTEM
Manufacturer
A PLUS MEDICAL
Date Cleared
2010-05-13
(162 days)
Product Code
BZD, 868
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.
Device Description
Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. Pre-conditioned gas (heat, moisture, flow and oxygen concentration) is provided to the device's inspiratory circuit. The gas is channeled to the nasal cannula for inhalation. Expired gas is channeled away from the nasal cannula and eventually is vented to the surrounding environment. The device also includes a pressure monitor nasal prong (proximal airway) pressure.
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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?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
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
K090317Device Name
BABI*PLUS BUBBLE PAP VALVE
Manufacturer
A PLUS MEDICAL
Date Cleared
2009-05-20
(100 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
A PLUS MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.
Device Description
Single patient use water seal positive end expiratory pressure device.
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