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510(k) Data Aggregation
K Number
K182164Device Name
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
Manufacturer
Ecolab Inc.
Date Cleared
2019-03-29
(231 days)
Product Code
NHV
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
Ecolab Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ecolab POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. Ecolab POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.
The Ecolab POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection or production of fluids for use in dialysis treatments.
Device Description
The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.
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K Number
K173164Device Name
Ecolab POU Water Filter
Manufacturer
Ecolab Inc.
Date Cleared
2018-06-29
(273 days)
Product Code
NHV
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
Ecolab Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECOLAB POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. ECOLAB POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.
The POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
Device Description
The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.
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K Number
K150190Device Name
IntraTemp Solution Warmer
Manufacturer
Ecolab Inc.
Date Cleared
2015-02-26
(30 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
Ecolab Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.
Device Description
Not Found
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