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510(k) Data Aggregation
K Number
K014281Device Name
GARD FILTER, COMBIGARD FILTE / HME
Manufacturer
MUNKTELL FILTER AB
Date Cleared
2002-06-26
(181 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
MUNKTELL FILTER AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.
Device Description
The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.
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K Number
K014282Device Name
BACSTOP FILTER,BACSTOP FILTER/HME
Manufacturer
MUNKTELL FILTER AB
Date Cleared
2002-06-26
(181 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
MUNKTELL FILTER AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).
Single patient use. Duration of use up to 24 hours.
Device Description
The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
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