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Found 10 results
510(k) Data Aggregation
K Number
K130511Device Name
CITRISOL ACID CONCENTRATE
Manufacturer
DIASOL, INC.
Date Cleared
2014-02-10
(348 days)
Product Code
KPO, NAM
Regulation Number
876.5820Why 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
K020231Device Name
DIASOL-ADDITIVES
Manufacturer
DIASOL, INC.
Date Cleared
2002-10-21
(271 days)
Product Code
KPO
Regulation Number
876.5820Why 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
K020230Device Name
DIASOL-BICARB
Manufacturer
DIASOL, INC.
Date Cleared
2002-04-23
(90 days)
Product Code
KPO
Regulation Number
876.5820Why 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
K011004Device Name
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
Manufacturer
DIASOL, INC.
Date Cleared
2001-05-24
(50 days)
Product Code
FMI
Regulation Number
880.5570Why 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
K010958Device Name
FISTULOK FISTULA NEEDLE PROTECTION
Manufacturer
DIASOL, INC.
Date Cleared
2001-05-18
(49 days)
Product Code
FMI
Regulation Number
880.5570Why 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
K011003Device Name
SAFESTING AND SAFESTING HUB
Manufacturer
DIASOL, INC.
Date Cleared
2001-04-20
(16 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K992999Device Name
DAISY PROTECTED SCALP VEIN SET
Manufacturer
DIASOL, INC.
Date Cleared
1999-11-05
(59 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K993187Device Name
SHELLY PROTECTED AV FISTULA NEEDLE
Manufacturer
DIASOL, INC.
Date Cleared
1999-11-05
(43 days)
Product Code
FPA
Regulation Number
880.5440Why 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
K992653Device Name
SHELLY PROTECTED AV FISTULA NEEDLE
Manufacturer
DIASOL, INC.
Date Cleared
1999-10-27
(82 days)
Product Code
FIE
Regulation Number
876.5540Why 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
K993212Device Name
DRYASOL ACID CONCENTRATE MIX
Manufacturer
DIASOL, INC.
Date Cleared
1999-10-22
(28 days)
Product Code
KPO
Regulation Number
876.5820Why 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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