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510(k) Data Aggregation
K Number
K153434Device Name
Pall-Aquasafe Water Filter
Manufacturer
PALL INTERNATIONAL, SARL
Date Cleared
2016-06-10
(196 days)
Product Code
NHV
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
PALL INTERNATIONAL, SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pall-Aquasafe™ Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water.
Device Description
The Pall-Aquasafe™ Water Filter is supplied sterile and integrity tested. The Supor® membrane within the filter cartridge is rated and validated at 0.2 micron to remove bacteria, protozoa, fungi and particles in the water supply. It is designed to be used for a maximum of one calendar month (31 days) following initial connection. Suspending use does not extend filter life. The Pall-Aquasafe Water Filter is intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immune-compromised patients may be exposed to waterborne microorganisms originating from the water supply.
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