CitriSol

Primary DI
B467CS10000010100
Brand
CitriSol
Company
DIASOL, INC.
Model
CS100000-10100
Catalog number
CSG1
Device description
CitriSol Liquid Acid Concentrate for Bicarbonate Dialysis
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130511000CITRISOL ACID CONCENTRATEDiasol, Inc.2014-02-10KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B467CS100000101004PackageHIBCC4In Commercial Distribution
B467CS1000001010055PackageHIBCC1In Commercial Distribution
B467CS10000010100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep from freezing and excessive heat.

Contacts#

Phone, Email table
PhoneEmail
818-838-7077Diasolinc@gmail.com

Regulatory Flags#

DUNS number
068434658
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B46710000075100DIASOL100000-75100ACD15-ACG302017-02-13
B46710000075200DIASOL100000-75200ACG12017-02-13
B46710001575100DIASOL100015-75100ACG312017-02-24
B46710001575200DIASOL100015-75200ACG22017-02-13
B46710002075100DIASOL100020-75100ACG322017-02-24
B46710002075200DIASOL100020-75200ACG32017-02-14
B467100022510100DIASOL1000225-10100ACG332017-02-13
B467100022575100DIASOL1000225-75100ACG342017-02-24
B467100022575200DIASOL1000225-75200ACG42017-02-13
B46710002575100DIASOL100025-75100ACG352017-02-14
B46710002575200DIASOL100025-75200ACG52017-02-13
B46710003510100DIASOL100035-10100ACG362017-02-24
B46710010010100DIASOL100100-10100ACG372017-02-24
B46710010075100DIASOL100100-75100ACG382017-02-24
B46710010075200DIASOL100100-75200ACG62017-02-14
B46710011010100DIASOL100110-10100ACG392017-02-24
B46710011575100DIASOL100115-75100ACG402017-02-24
B46710012010100DIASOL100120-10100ACGG412017-02-14
B46710012075100DIASOL100120-75100ACD16-ACG422017-02-14
B46710012075200DIASOL100120-75200ACD1-ACG72017-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10857940006688Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
38051411600351HMB32HAEMOPHARM BIOFLUIDS SRLKPO2021-07-03
38051411600061HMB32HAEMOPHARM BIOFLUIDS SRLKPO2020-03-11
M535RFP211WW0NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2018-10-01
10857940006664HEMO-DIALEDLAW PHARMACEUTICALS, INC.KPO2017-12-22
10857940006657Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-10-06
10857940006640Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-10-04
10857940006633Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-04-17
10857940006626Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-03-15
B46710013075100DIASOLDIASOL, INC.KPO2017-02-28
B46710020010100DIASOLDIASOL, INC.KPO2017-02-28
B46710021075100DIASOLDIASOL, INC.KPO2017-02-28
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B46710043575100DIASOLDIASOL, INC.KPO2017-02-28
B4677811510200DIASOLDIASOL, INC.KPO2017-02-28
B4677812010200DIASOLDIASOL, INC.KPO2017-02-28
B4677821510200DIASOLDIASOL, INC.KPO2017-02-28
B4677822010200DIASOLDIASOL, INC.KPO2017-02-28