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510(k) Data Aggregation

    K Number
    K222727
    Device Name
    i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
    Manufacturer
    i3 Membrane GmbH
    Date Cleared
    2023-06-02

    (267 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the i3 Membrane Water Filters i3 ONE, i3 TWO connect, i3 TWO direct is to filter EPA quality drinking water. The i3 Membrane Water Filters retain bacteria, which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The i3 Membrane Water Filters are not intended to provide water that can be used as a substitute for USP grade sterile water.
    Device Description
    The i3 Point-of-Use Water Filters are supplied sterile and 100% integrity tested. The membrane within the filter cartridge is rated and validated at 0.2 µm to remove bacteria and particles in the water supply. This membrane reduces bacteria with more than 7 log levels per square centimeter filtration area. This represents the bacterial retention, the core element of infection prevention. Furthermore, a bacteriostatic additive is present in the outer housings parts of the filter, which prevents retrograde contamination of the filter. In addition, the inlet of the tap water filter is inclined to prevent the water from hitting the siphon. This also prevents retrograde contamination from the siphon, which would be caused by rising aerosols from the direct impact of the water jet. The Water Filters are designed to be used for a maximum of 50 days following initial connection. Suspending use does not extend filter life. The i3 ONE / i3 TWO connect / i3 TWO direct Water Filters are intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply. The i3 Membrane Water Filters are disposable and designed for the use on tap or the shower.
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    K Number
    K191563
    Device Name
    FILTRAY 2G Disposable Water Filters
    Manufacturer
    aqua-tools
    Date Cleared
    2019-10-25

    (134 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aqua-tools FILT'RAY 2G Disposable Water Filter is intended 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 FILT'RAY 20 Disposable Water Filters are intended to produce bacteriologically controlled, purified water for general medical uses (e.g., washing of surgeon's hands, surgical instruments, and cleansing). These devices retain bacteria including opportunistic waterborne pathogenic microorganisms via a hollow fiber microfiltration technology with a corresponding pore size of 0.1 µm nominal / 0.2 µm absolute. This microfiltration technology ensures that the purified water will meets the criteria of bacteriologically controlled water that presents a higher bacteriological quality than the water of the distribution network by retaining bacteria, including Legionella spp., L. pneumophila. Pseudomonas aeruginosa and other opportunistic waterborne pathogenic microorganisms. Of note, the subject FILT'RAY 20 devices do not contain latex, nor tissues or by-product animal origins, nor derived of blood or any substance considered as a medicine. The subject FILT' RAY 20 devices are provided sterile and are designed to be used for 1 month up to 4 months after initial connection and depending on the specific model.
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    K Number
    K182164
    Device 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
    876.5665
    Why did this record match?
    Product Code :

    NHV

    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
    K173164
    Device Name
    Ecolab POU Water Filter
    Manufacturer
    Ecolab Inc.
    Date Cleared
    2018-06-29

    (273 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    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
    K163609
    Device Name
    Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
    Manufacturer
    PALL INTERNATIONAL SARL
    Date Cleared
    2017-06-01

    (161 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pall® QPoint™ Water Filter Capsule is intended to be used within the healthcare environment such as hospitals, nursing homes, healthcare facilities or clinical setting where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply. The Pall QPoint™ Water Filter Capsule is intended to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, fungi and protozoa 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 filter is not intended to provide water that can be used as a substitute for USP grade sterile water.
    Device Description
    The Pall QPoint™ Water Filter Capsule is a disposable filter capsule comprised of polyester, polypropylene, and polyethersulphone. The product is not made with natural rubber latex. The filter does not come into direct contact with patients, but indirect contact occurs as the water flowing through the filter is used by patients and by surgeons operating on patients. Every device batch is integrity tested prior to release, and the filter capsules are supplied sterile. The Qpoint™ filter is a single-use device, i.e., it should not be removed and then re-used; however, a filter capsule can be used for up to two calendar months (maximum 62 days) following initial connection. A double layer Supor® membrane within the filter capsule is rated and validated at 0.2 µm to remove bacteria, fungi, protozoa and particles in the water supply. The filter membrane also has a high-technology integrated pre-filtration layer to provide extended use with higher dirt capacity for better flow rates. The Filter Capsule is designed to be used with a fixed reusable Docking Station (i.e., Shower or Faucet Assembly, also called a Filter Capsule holder). The fitter capsule must be connected to a docking station in order to be used, but it can be exchanged when required without discarding the holder, which have separate reorder codes. The Docking Station need only be exchanged if obvious functional damage is found (e.g., a leak) or when aesthetic wear leads the user to prfer replacing this component.
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    K Number
    K161467
    Device Name
    HydraGuard 10 UltraFilter
    Manufacturer
    NEPHROS INC.
    Date Cleared
    2016-12-22

    (209 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.
    Device Description
    Not Found
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    K Number
    K153784
    Device Name
    NOSOGARD FILTERS
    Manufacturer
    Evoqua Water Technologies, LLC
    Date Cleared
    2016-10-21

    (295 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired. The Nosogard is 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
    Nosogard Filters are disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in the drinking water supply is desired for device cleaning, handwashing and bathing applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head.
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    K Number
    K153434
    Device Name
    Pall-Aquasafe Water Filter
    Manufacturer
    PALL INTERNATIONAL, SARL
    Date Cleared
    2016-06-10

    (196 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    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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    K Number
    K153084
    Device Name
    Nephros S100
    Manufacturer
    NEPHROS INC.
    Date Cleared
    2016-04-08

    (165 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.
    Device Description
    The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.
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    K Number
    K141731
    Device Name
    NEPHROS DSU-H, NEPHROS SSU-H
    Manufacturer
    NEPHROS, INC.
    Date Cleared
    2014-10-24

    (119 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    NHV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, 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 sterile water.
    Device Description
    The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.
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