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510(k) Data Aggregation
K Number
K162343Device Name
Westmed Gas Sampling Cannula with O2 delivery
Manufacturer
WESTMED, INC.
Date Cleared
2016-12-14
(114 days)
Product Code
CCK, CAT
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
WESTMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use < 24 hours.
Device Description
Westmed has designed several 0%CO2 nasal cannula / exhaled gas sampling devices. They include:
- . Nasal cannula style that can provide supplemental O2 and sample exhaled gases at only the nares and
- Nasal cannula style that can provide supplemental O2 and sample exhaled gases at both ● the nares and at the mouth
The device configurations include nasal cannula that have a division to deliver oxygen through one nare and to sample exhaled gases through the other. There is also an oral sampling style which is positioned near the mouth to sample exhaled gases if the patient is a mouth breather.
The device includes a length of standard oxygen tubing and gas sampling lines.
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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?
Applicant Name (Manufacturer) :
Westmed, Inc.
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
K133057Device Name
VIBRALUNG ACOUSTICAL PERCUSSOR
Manufacturer
Westmed, Inc.
Date Cleared
2014-05-23
(238 days)
Product Code
SDT, BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
Westmed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.
Device Description
The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.
The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.
In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.
There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces.
The purpose of the Y-adapters is two-fold:
- · To direct the sound waves into the airway opening, and
- · To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.
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K Number
K121382Device Name
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
Manufacturer
Westmed, Inc.
Date Cleared
2012-12-06
(212 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
Westmed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Westmed, Inc. BlockAide™ Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.
Device Description
The BlockAide™ Filter, manufactured by Westmed, Inc., is a disposable, single-use barrier type, bi-directional filter fabricated from a plastic resin that is supplied to the customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.
The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from an opaque plastic and the machine housings are fabricated from the same plastic but with different number molded into the housing to identify machine end. The numbered end fits the machine and the opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.
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K Number
K081905Device Name
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
Manufacturer
Westmed, Inc.
Date Cleared
2008-07-15
(12 days)
Product Code
MEB
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
Westmed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AccuFlo & AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert.
The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes
The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
Device Description
The AccuFlo & AccuFlux models are both disposable, non-electric infusion pumps that deliver precise volume of medication at predetermined flow rate for IV therapy.
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K Number
K072220Device Name
PEDI CO2 EASY
Manufacturer
Westmed, Inc.
Date Cleared
2007-08-23
(13 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Westmed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use during mask ventilation to assist in the determination of a patent airway.
Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.
Device Description
Not Found
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K Number
K070128Device Name
CO2 EASY
Manufacturer
Westmed, Inc.
Date Cleared
2007-02-15
(30 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Westmed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use during mask ventilation to assist in the determination of a patent airway. Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.
Device Description
Not Found
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