Dry Bicarb Mixing System

Primary DI
00814963021459
Brand
Dry Bicarb Mixing System
Company
ROCKWELL MEDICAL, INC.
Model
BCMIX100
Catalog number
BCMIX100
Published
2018-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K022521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022521000BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLONRockwell Medical Technologies, Inc.2003-01-03KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814963021459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814963021459008149630214598149630214590814963021459

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system fluid mixerAn electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933721433
Device count
1
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857940006671Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
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
B46710021575100DIASOLDIASOL, INC.KPO2017-02-28
B46710023510100DIASOLDIASOL, INC.KPO2017-02-28
B46710031075100DIASOLDIASOL, INC.KPO2017-02-28
B46710031575100DIASOLDIASOL, INC.KPO2017-02-28
B46710032010100DIASOLDIASOL, INC.KPO2017-02-28
B46710032075100DIASOLDIASOL, INC.KPO2017-02-28
B46710032525100DIASOLDIASOL, INC.KPO2017-02-28
B46710033510100DIASOLDIASOL, INC.KPO2017-02-28
B46710033575100DIASOLDIASOL, INC.KPO2017-02-28
B46710042075100DIASOLDIASOL, INC.KPO2017-02-28
B467100422575100DIASOLDIASOL, INC.KPO2017-02-28
B46710043075100DIASOLDIASOL, INC.KPO2017-02-28
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