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510(k) Data Aggregation

    K Number
    K130511
    Device Name
    CITRISOL ACID CONCENTRATE
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2014-02-10

    (348 days)

    Product Code
    KPO, NAM
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.
    Device Description
    CitriSol is manufactured following strict cGMP's and in accordance with the AAMI/ANSI/ISO 13958:2009 concentrates for hemodialysis and AAMI/ISCHANSI 13959:2009 Water for Hemodialysis. Our product codes are easy to understand. The electrolytes present in each solution. Preceded by CS representing the Citric Acid part. In the 45x proportioning formulations the first three numbers -100 stand for the Na. followed by K (ex 2). Ca (25). -Mg (75). This example stands for CS 100225-75 a 2K 2.5 Ca product. CitriSol acid concentrate comes in liquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below: 45X LIQUID, 36.83X LIQUID, 35X LIQUID, POWDER. CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid. CitriSol, when mixed with ANSI/AAMI/ISO standard water for hemodialysis, has the same chemical equivalence as the predicates.
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    K Number
    K020231
    Device Name
    DIASOL-ADDITIVES
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2002-10-21

    (271 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs . puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.
    Device Description
    Not Found
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    K Number
    K020230
    Device Name
    DIASOL-BICARB
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2002-04-23

    (90 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.
    Device Description
    Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAM standard water and Acid Concentrate, it creates a dialysate solution for use in renal dialysis therapy. read diarysis therepy . Diasol-BiCarb solution is in a ready to use form that is convenient for use in chronic care dialysis unit as well as acute care, dialysis thin as well as noter care. Sodium bicarbonate Hemodialysis grade, a white, water soluble powder is mixed with South block one of the case your Chloride USP (for 36.83 proportioning) in adequate proportions to provide the bicarbonate part of the dialysate. proportions to provide the breat benefits plastic container (HDPE) similar to the predicate. The solution is non-sterile, non-pyrogenic. Finished product is gamma radiated. The southout is non-centions have been taken to assure that the finished product does not promote bacterial growth.
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    K Number
    K011004
    Device Name
    NEEDLELOK HYPODERMIC NEEDLE PROTECTION
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2001-05-24

    (50 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010958
    Device Name
    FISTULOK FISTULA NEEDLE PROTECTION
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2001-05-18

    (49 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011003
    Device Name
    SAFESTING AND SAFESTING HUB
    Manufacturer
    DIASOL, INC.
    Date Cleared
    2001-04-20

    (16 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992999
    Device Name
    DAISY PROTECTED SCALP VEIN SET
    Manufacturer
    DIASOL, INC.
    Date Cleared
    1999-11-05

    (59 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides access to patients vascular system to administer IV fluids Is used in blood drawing Aid in prevention of needlestick injury.
    Device Description
    Daisy Protected Scalp Vein Set
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    K Number
    K993187
    Device Name
    SHELLY PROTECTED AV FISTULA NEEDLE
    Manufacturer
    DIASOL, INC.
    Date Cleared
    1999-11-05

    (43 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.
    Device Description
    Shelly Protected Fistula Needle has a shield that when activated enclose the needle.
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    K Number
    K992653
    Device Name
    SHELLY PROTECTED AV FISTULA NEEDLE
    Manufacturer
    DIASOL, INC.
    Date Cleared
    1999-10-27

    (82 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fistula needle is part of the Hemodialysis system that provides access to the patient's blood. It is also used in plasmapheresis for the same purpose.
    Device Description
    Shelly AV Fistula Needle
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    K Number
    K993212
    Device Name
    DRYASOL ACID CONCENTRATE MIX
    Manufacturer
    DIASOL, INC.
    Date Cleared
    1999-10-22

    (28 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASOL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dryasol Acid Concentrate mix is indicated for use in acute and chronic hemodialysis. It is an accessory to be used with the appropriate hemodialysis machine in the exact prescribed proportion with RO water and Sodium Bicarbonate Mix.
    Device Description
    Not Found
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