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510(k) Data Aggregation
K Number
K050990Device Name
REMREST HEATED HUMIDIFIER
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
2005-05-02
(13 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INDUSTRIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.
Device Description
The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications: Size 13.1" L x 8.4" W x 4.7" H, Weight 2.5 lbs. dry, Water capacity 400 ml (1 2/3 cups), Power 100-240 VAC 50/60Hz or 1.0 A max., Heater setting 1-5 (85°F to 149°F / 29.4°C to 65°C), Humidity Range 30 mg H2O/l @ 25 lpm, Pressure drop 0.5 cm H2O @ 40 lpm.
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K Number
K032170Device Name
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
2004-05-28
(317 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INDUSTRIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TransNeb compressor/nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a venturi (pneumatic nebulizer) to convert certain inhaled drugs into an acrosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
Device Description
The TransNeb system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the TransNeb device offers the user a choice of running off of AC power via a universal adapter or DC power via an option 12 volt auto adapter or an optional rechargeable battery pack. The device consists of a motor driven piston compressor, a printed circuit board and a switch. The circuit board does not incorporate a microprocessor but serves as a means to prevent double feed of power. The circuit board is not a part of the charging circuit for the battery pack. The nebulizer, which employs a venturi effect to convert the medication into a fine aerosol mist, is used cither snapped directly onto the compressor outlet barb or with an extension tube. Providing a connection between the compressor outlet barb and the nebulizer bottom, the extension tube allows the user to place the compressor on a sturdy surface and to simply hold onto the nebulizer. The nebulizer is designed for single patient and is reusable. The nebulizer with or without its tubing adapter is designed specifically for use only with the TransNeb compressor.
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K Number
K002763Device Name
REMREST
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
2001-05-04
(241 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INDUSTRIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011053Device Name
OPTIMA
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
2001-04-20
(14 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INDUSTRIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964078Device Name
3050 SPORT-NEB
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
1997-01-10
(91 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INDUSTRIES AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.
Device Description
The Model 3050 "sport-Neb" is a small, lightweight, nebulizer compressor. It measures 7 1/2" X 7 1/2" X 4 1/2" The housing is groupe The housing is grey switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer. The handle is built into the housing The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.
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