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510(k) Data Aggregation
K Number
K093426Device Name
BACT-TRAP HEPA MIDI
Manufacturer
Date Cleared
2010-02-22
(111 days)
Product Code
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
PHARMA SYSTEMS AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. It is single patient use, disposable for patients with Tidal Volumes > 150 ml.
May be positioned at the machine end of the expiratory / inspiratory limb of the circuit, or at the patient end of the circuit.
Device Description
The Bact-Trap™ HEPA Midi filter incorporates standard 15 / 22 mm connectors with a gas sampling luer port. It utilizes an electrostatic media for the filtration function. The "HEPA" performance was tested in accordance to DOE 3020-97 and ASTM D2986 - 95a DOP at 30 Ipm.
The filter functions by electrostatic capture.
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