Citric Complete

Primary DI
00817411021124
Brand
Citric Complete
Company
DIMESOL USA, LLC
Model
DCA-201
Device description
Dry Citric Acid
Published
2018-10-23
Public version status
New
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
K171750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171750000Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC2018-03-06KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817411021124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817411021124008174110211248174110211240817411021124

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069723499
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817411021117Citric CompleteDCA-2002018-10-23
00817411021131Citric CompleteDCA-2022018-10-23
00817411021148Citric CompleteDCA-2032018-10-23
00817411021155Citric CompleteDCA-2062018-10-23
00817411021162Citric CompleteDCA-2252018-10-23
00817411021179Citric CompleteDCA-2262018-10-23
00817411021186Citric CompleteDCA-2282018-10-23
00817411021100Citric CompleteDCA-2312018-07-31
00817411020264MedicaLyteBC-3002018-07-25
00817411020332MedicaPureAC-1002018-07-25
00817411021094MedicaLyteBC-2002018-07-25
10817411020261MedicaLyteBC-3002018-07-25
10817411020339MedicaPureAC-1002018-07-25
30817411021095MedicaLyteBC-2002018-07-25
00817411020066MedicaPureAC-2012017-03-23
00817411020080MedicaPureAC-2022017-03-23
00817411020165MedicaPureAC-2062016-12-12
00817411020240MedicaLyteBC-1002017-03-23
00817411020257MedicaLyteBC-2012016-11-11
00817411020271MedicaLyteDB-100-2.52017-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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B46710020010100DIASOLDIASOL, INC.KPO2017-02-28
B46710021075100DIASOLDIASOL, INC.KPO2017-02-28
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B46710042075100DIASOLDIASOL, INC.KPO2017-02-28
B467100422575100DIASOLDIASOL, INC.KPO2017-02-28
B46710043075100DIASOLDIASOL, INC.KPO2017-02-28
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