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510(k) Data Aggregation
K Number
K201666Device Name
SINGLE USE MANOMETER
Manufacturer
Flexicare Medical Limited
Date Cleared
2020-11-13
(147 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Device Description
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
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K Number
K182292Device Name
VORTRAN APM-Plus
Manufacturer
VORTRAN Medical Technology 1, Inc.
Date Cleared
2019-09-18
(391 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.
Device Description
The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.
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K Number
K180510Device Name
NS 120P-TRS Airway Pressure Gauge
Manufacturer
Instrumentation Industries, Inc.
Date Cleared
2019-05-01
(428 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.
Device Description
The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.
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K Number
K172284Device Name
NAPA LP-15 Airway Pressure Monitor
Manufacturer
DRW Medical, LLC
Date Cleared
2018-02-09
(196 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
Device Description
The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
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K Number
K153733Device Name
VORTRAN Manometer
Manufacturer
VORTRAN MEDICAL TECHNOLOGY 1, INC.
Date Cleared
2016-09-16
(263 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient's airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.
Device Description
The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.
The manometer label has three color zones of green, yellow, and red to give enhanced visual support during ventilation. The color coded scale indicates the following: green is 0 to 20 cm-H2O; yellow is 20 to 40 cm-H2O, and red is for pressures above 40 cm-H2O. The color coded scale is only for visual support and the correct ventilation pressure must be determined by the medical professional.
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K Number
K143148Device Name
Disposable Pressure Manometer (DPM)
Manufacturer
Westmed, Inc.
Date Cleared
2015-08-11
(281 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.
For patients that the clinician desires to monitor or measure airway or circuit pressure.
Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
Device Description
The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.
The device consists of:
- 1. Clear housing with a printed pressure scale
- 2. A float with indicator and
- 3. Spring
It functions by reacting to the positive present in the ventilation device. When pressure is in the device the float moves up or down to indicate the pressure of the system. This manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range -0-60 cm H2O. The performance characteristics are that the measured pressures are accurate to:
- + 3 cm H2O up to 60 cm H2O
It is a single patient, disposable, packaged non-sterile device.
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K Number
K140370Device Name
DISPOSABLE PRESSURE MANOMETER
Manufacturer
BESMED HEALTH BUSINESS CORP.
Date Cleared
2014-06-19
(125 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits, For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home. Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
Device Description
The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: 1. A flexible nipple for attachment to a sampling / pressure port. 2. Clear housing with a printed pressure scale 3. A float with indicator 4. Spring. When positive pressure is present in the ventilation device, the manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range - 0-60 cm H2O. Besmed intends offer three (3) models / styles of their disposable pressure manometer. They are identical in design, function and materials. The differences are: Pressure range. 0 0 60 cm H2O 0 40 cm H2O · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design Note the accuracy and performances are identical . Indicator strip . O All models have the pressure range embossed on the housing o A color strip / indicator may also be included to indicate the pressure. It is a single patient, disposable, packaged non-sterile device.
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K Number
K122627Device Name
GIO DIGITAL PRESSURE GUAGES
Manufacturer
GALEMED CORP.
Date Cleared
2013-08-22
(359 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.
Device Description
The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated. The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.
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K Number
K122077Device Name
MANOMETER
Manufacturer
INTERSURGICAL, INC.
Date Cleared
2013-01-10
(178 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intersurgical In-line single patient use manometer is intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems and Mapleson C breathing circuits.
Device Description
The Intersurgical 7160030 Manometer is an inline manometer for monitoring the pressure delivered to patients via resuscitation systems and Mapleson C breathing circuits. The 7160030 manometer has an operating range of 0 - 60 mbar and a stated accuracy. of +/- 10mbar. The pressure is read where the internal red indicator disk lines up with the pressure indication mark on the outside of the transparent manometer cylinder. The 7160030 manometer specify the patient pressure via a brightly colored indicator. The indicator moves in one axis along a transparent cylinder. The diameter of the indicator is similar to that of the cylinder. A balance of the force exerted by the air in the system and the force exerted by a calibrated spring defines the indicator position. The display on each manometer is a similar size and the pressure is specified where the indicator lines up with number marked on the outside of the transparent cylinder. The Manometer connects to the resuscitator / Mapleson C system via a 3 way, 15mm Female/22mm Male - 22mm Female connector. The 3-way connector tapers are compliant with ISO 5356-1. The manometer can be rotated to the desired orientation for ease of use via a friction fit elastomeric elbow. The 7160030 Manometer is single patient use.
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K Number
K120118Device Name
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
Manufacturer
VENTLAB CORP.
Date Cleared
2012-05-24
(128 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Product Code :
CAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.
Device Description
Ventlab Pressure-Chek Disposable Column Manometer
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