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510(k) Data Aggregation
K Number
K091363Device Name
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
Manufacturer
AG INDUSTRIES
Date Cleared
2010-02-04
(272 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
AG INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility, etc.
Device Description
Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, the air passes through the Compressor Filter, if one is installed on the machine and proceeds to the sieve beds. The sieve beds condition the air by removing nitrogen from the air stream, which results in higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
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K Number
K052087Device Name
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
Manufacturer
AG INDUSTRIES
Date Cleared
2005-12-14
(134 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
AG INDUSTRIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AG Industries Breathing Filter Bacterial/Viral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical that may our and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.
Device Description
The Breathing Filter is a replacement filter for use mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines. The product is composed of 3 main elements. These include a top housing, a bottom housing, and a filter element. The filter material is secured in the top and bottom housing using a sonic weld joint.
* The top housing is made of plastic and has a clear polish finish and has a standard 22mm ID connection port.
* The bottom housing is made of plastic and has a clear polish finish and has a standard 15mm ID/22mm OD connection port for universal usage.
* The filter element is composed of electrostatic material, with a bonded scrim, on one side of the filter element only.
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