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Found 16 results
510(k) Data Aggregation
K Number
K142096Device Name
T-PIECE RESUSCITATOR
Manufacturer
MERCURY MEDICAL
Date Cleared
2014-10-17
(77 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).
Device Description
The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).
It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.
The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.
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K Number
K093913Device Name
MERCURY MEDICAL T-PIECE RESUSCITATOR
Manufacturer
MERCURY MEDICAL, INC.
Date Cleared
2010-04-06
(105 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neo-Tee™ T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb).
Device Description
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants < 10 kg (22 lb). It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure. The Mercury Medical T-Piece Resuscitator (Neo-Tee™) can be connected to the patient via a face mask or endotracheal tube.
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K Number
K090710Device Name
MERCURY CPAP
Manufacturer
MERCURY MEDICAL
Date Cleared
2009-08-20
(155 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
Device Description
The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.
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K Number
K081266Device Name
MERCURY MEDICAL PEEP VALVE
Manufacturer
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
Date Cleared
2009-03-05
(304 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
MERCURY ENTERPRIZES DBA MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.
Device Description
Not Found
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K Number
K083056Device Name
NEO-STAT CO2 <KG
Manufacturer
MERCURY MEDICAL
Date Cleared
2009-02-23
(132 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neo-StatCO2 <Kg is indicated to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.
Device Description
Mercury Medical, Inc. Neo-StatCO2 <Kg is a colorimetric breath indicator for visualization of exhaled CO2. It is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. Color change is rapid and the detector has the ability to show color changes with 1 ml tidal volume and up to a respiratory rate of 100 breaths per minute. The detector may be used during patient transport or in locations when intubations are performed. While the indicator functions at relative humidity (RH) of up to 100%, it is not recommended for use below 10% RH. It may be used for up to 24 hours.
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K Number
K032593Device Name
MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
Manufacturer
MERCURY MEDICAL
Date Cleared
2004-02-03
(165 days)
Product Code
BXR
Regulation Number
868.1780Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.
Device Description
The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.
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K Number
K031814Device Name
STATCO2METER, MODEL 10-55372
Manufacturer
MERCURY MEDICAL
Date Cleared
2003-08-14
(63 days)
Product Code
CCK, CAP
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
Device Description
The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. The detector may be used during patient transport or in locations where intubations are performed.
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K Number
K031411Device Name
MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
Manufacturer
MERCURY MEDICAL
Date Cleared
2003-07-30
(86 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury Medical Mini StatCO2™ End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
Device Description
The Mercury Medical Mini StatCO2™ uses the same technology as the Nellcor Pedi-CAP™ (K944400). The Mini StatCQ2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.
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K Number
K021576Device Name
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
Manufacturer
MERCURY MEDICAL
Date Cleared
2002-11-04
(174 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercury Medical STATCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
Device Description
The Mercury Medical STATCO2™ uses the same technology as the Nellcor Easy Cap II, (K894053, FENEM submitter). The STATCO2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.
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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?
Applicant Name (Manufacturer) :
MERCURY MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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