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Found 5 results
510(k) Data Aggregation
K Number
K972397Device Name
EZ SPRAY
Manufacturer
INTERTEX RESEARCH, INC.
Date Cleared
1997-09-23
(89 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Product Code :
CCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZ-Sprayer is intended to apply topically by spray or atomizing an oil or water base solution to either the nose and / or throat, for example, topical anesthetics solutions of lidocaine or xylocaine.
The device will not be supplied with water or oil base solutions.
Device Description
The disposable, air or gas powered venturi sprayer / atomizer with reservoir and spring loaded flow control button, with an adjustable spray nozzle.
A disposable, nose or throat atomizer for either oil or water base solutions.
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K Number
K964956Device Name
E-Z SPACER MASK (SMALL)
Manufacturer
AIRPHARMA, LLC
Date Cleared
1997-04-23
(133 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Product Code :
CCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The E-Z SPACER® Mask (Small) uses FDA approved materials: Dynaflex G2706 Kraton thermoplasiic rubber designed for medical applications, and 21 CFR 178.3297 colorant pigments as specified by the Food and Drug Administration (Colorants for polymers). The E-Z SPACER Mask is injected molded with cavity I.D. mask (E-Z SPACER®MASK (Small) for identification.
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K Number
K961894Device Name
MDI TUTOR
Manufacturer
MDI TUTOR, INC.
Date Cleared
1996-08-14
(90 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Product Code :
CCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.
Device Description
The device is a simple plastic cylinder designed to fit flush over the mouthpieces of inhalers supplied by Schering (Proventil and Vanceril), Allen and Hanburys (Ventolin and Serevent), and Warrick (Albuterol). A whistle mechanism on the device is activated by the user during inspiration. The accessory device does not introduce additional space to the metered dose inhaler or interfere with the performance of the inhaler. The whistle reminds the user to sustain a slow continuous inspiration when using the metered dose inhaler.
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K Number
K961455Device Name
MEDSHIELD/AEROCHAMBER
Manufacturer
DIEMOLDING CORP.
Date Cleared
1996-07-25
(100 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Product Code :
CCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DHD MedShield is a single-patient-use device. The Intended Use of the device is to reduce the taste effect of Metered Dose Inhaler (MDI) drugs by covering the tongue in the taste sensor area.
Device Description
The MedShield product reduces drug deposition in the tongue when used in conjunction with metered dose inhaler (MDI) medications. The device attaches to an MDI elbow and shields the tongue of the user from the medication spray. Drug that deposits on the device would otherwise be on the users tongue. Based on this, the taste effect of the medications is reduced. This simple device includes two different features. 1. The patient end of the device covers the tongue. The patient end may vary to maximize the comfort of a wide range of users. 2. The elbow end of the device includes a universal clip, which attaches the device to all MDI elbows. To satisfy the preferences of various customers, the force required to separate (or attach) the device to various elbows can be modified by adjusting the clip or modifying the taper around the clip. The MedShield product has been designed to conform with ASTM F963-92, "Standard Consumer Safety Specification on Toy Safety, under Section 4.6, Small Objects, specifically 4.6.2, Mouth-Actuated Toys, and CFR 16-1511.1, "Requirements For Pacifically, 1511.5 Structural integrity tests for Small Parts, 1511.5 (d), to ensure that the device does not present a choke hazard. The MedShield is designed for single patient use. Patients may be given the product for use either in a hospital or home environment for extended time periods. Recommendations for cleaning, in cases of extended time, are included in the instructions for use.
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K Number
K960593Device Name
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
Manufacturer
ARADIGM CORP.
Date Cleared
1996-05-10
(88 days)
Product Code
CCQ
Regulation Number
868.5640Why did this record match?
Product Code :
CCQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.
Device Description
The Aradigm Corporation SmartMist™ Asthma Management System is a single patient use prescribed metered dose inhaler (MDI) accessory and peak flow meter. The SmartMist™ is composed of the non-disposable, battery powered, portable SmartMist™ Controller and the SmartMist™ Spirometry Airway. In addition to it; primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung function of patient compliance monitoring is available.
The SmartMist™ Asthma Management System is designed to work with a particular style of MDI, without modification. The entire MDI-canister and plastic actuator-is inserted into the SmartMist™ without the introduction of any flaps or valves. The MDI is easily removed for cleaning or for manual dosing should the SmartMist™ become inoperable.
As the patient inhales through their prescribed MDI that they have inserted into the SmartMist™, the device's microprocessor monitors the inhalation flow rate and volume detected by the system's pressure transducer. If the inhalation flow rate and volume fall within the factory programmed parameters, the microprocessor triggers its mechanism to actuate the MDI canister; aerosol medication is delivered to the patient.
Feedback regarding the inhalation flow rate is provided to the patient in the form of red and green LEDs. When the green LED is illuminated, the patient is breathing at the recommended inhalation rate for aerosol drug delivery.
The SmartMist™ Asthma Management System also functions as an electronic peak flow meter. When the user exhales through the Spirometry Airway, the device's microprocessor determines the peak expiratory flow rate (PEFR) and forced expiratory volume in one second (FEV). The peak flow rate is displayed to the patient in the liquid crystal display window.
A record of PEFR, FEV , and dosing (inhalation) events is stored in the SmartMist™ memory for later retrieval, if desired, by a trained medical practitioner. Therefore, the SmartMist™ also provides patient compliance monitoring at the option of the practitioner.
Use of MDI medications with the SmartMist™ provides to the patient continual inhalation technique training. Since the SmartMist™ will not deliver the medication unless the patient's inhalation is at the proper flow rate, the patient eceives technique feedback each time the SmartMist™ is used for delivery of medication. Red and green indicators provide easily understood flow rate feedback to the patient.
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