CitraPure

Primary DI
00814963020766
Brand
CitraPure
Company
ROCKWELL MEDICAL, INC.
Model
L4-107
Catalog number
L4-107
Published
2015-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K062399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062399000ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURERockwell Medical Technologies, Inc.2006-11-17KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814963020763PackageGS14In Commercial Distribution
00814963020766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081496302076310814963020763
00814963020766008149630207668149630207660814963020766

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
933721433
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814963021503CitraPureL4-137L4-1372025-07-28
00814963021497Dri-SateDC-136DC-1362025-02-06
00814963020735CitraPureL4-128L4-1282024-04-18
10814963020732CitraPureL4-128L4-1282024-04-18
00814963020001SterilyteCL-02CL-022015-09-15
00814963020186RenalPureC-114C-1142015-09-22
00814963020209RenalPureC-116C-1162015-09-22
00814963020223RenalPureC-117C-1172015-09-22
00814963021480RenalPureC-131C-1312019-06-17
10814963021487RenalPureC-131C-1312019-06-17
00814963021169CitraPureL3-134L3-1342015-09-28
00814963021176CitraPureL3-145L3-1452015-09-28
00814963021220CitraPureL4-011CL4-011C2016-05-09
00814963021237CitraPureL4-022CL4-022C2016-05-09
00814963021244CitraPureL4-033CL4-033C2016-05-09
00814963021268CitraPureL4-055CL4-055C2016-05-09
00814963021275CitraPureL4-066CL4-066C2016-05-09
0081496302130530% Acetic Acid SolutionR-300R-3002016-06-13
00814963021336RenalPureC-216C-2162017-01-20
00814963021343RenalPureC-224C-2242017-01-20

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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
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B4677822010200DIASOLDIASOL, INC.KPO2017-02-28