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510(k) Data Aggregation

    K Number
    K051370
    Device Name
    STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    2005-08-12

    (78 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.
    Device Description
    Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.
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    K Number
    K000265
    Device Name
    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2001-07-12

    (531 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000266
    Device Name
    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
    Manufacturer
    PRIMARY CARE SOLUTIONS, INC.
    Date Cleared
    2001-07-12

    (531 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003402
    Device Name
    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
    Manufacturer
    WELCON, INC.
    Date Cleared
    2001-05-01

    (181 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994321
    Device Name
    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    2000-10-25

    (308 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.
    Device Description
    Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives. The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.
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    K Number
    K974758
    Device Name
    HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
    Manufacturer
    HYDROX LABORATORIES
    Date Cleared
    1998-03-09

    (80 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such. The intended use of this device is the same as the intended use of similar devices currently in the market.
    Device Description
    Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle
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    K Number
    K974759
    Device Name
    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
    Manufacturer
    HYDROX LABORATORIES
    Date Cleared
    1998-03-09

    (80 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
    Device Description
    Sterile Saline 0.9% Sodium Chloride Solution
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    K Number
    K974397
    Device Name
    STERILE SALINE FOR CATHETER CARE
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1998-02-10

    (81 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Baxter Sterile Saline for Catheter Care is intended for use in flushing urinary drainage and suction catheters. Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.
    Device Description
    Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares in 250 mL containers.
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    K Number
    K973734
    Device Name
    STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
    Manufacturer
    WELCON, INC.
    Date Cleared
    1998-02-05

    (128 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sterile water and sterile saline are indicated for device irrigation only. The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.
    Device Description
    The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.
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    K Number
    K972372
    Device Name
    GERM TRAPPER SUCTION TUBE HOLDER
    Manufacturer
    RZV MEDICAL SPECIALTIES, INC.
    Date Cleared
    1997-12-11

    (169 days)

    Product Code
    JOL
    Regulation Number
    880.6740
    Why did this record match?
    Product Code :

    JOL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.
    Device Description
    The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.
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