FDA.reportPublic FDA data

Di-Chem Hemodialysate Additive

Primary DI
B637BAK111
Brand
Di-Chem Hemodialysate Additive
Company
Di-Chem, Incorporated
Model
BAK-11
Device description
Potassium chloride additive for bicarbonate dialysis.
Published
2019-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B637BAK111PrimaryHIBCC0
B637BAK110Unit of UseHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-847-2598info@dichem-us.com

Regulatory Flags#

DUNS number
108677253
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B637C25201030CitryteC25-201-032026-05-07
B637C25202090CitryteC25-202-092026-05-07
B637C25203210CitryteC25-203-212026-05-07
B637C25302180CitryteC25-302-182026-05-07
B637DB2151HEMO-LYTEDB-2-152026-05-07
B637DB2211HEMO-LYTEDB-2-2.12026-05-07
B637DB2251HEMO-LYTEDB-2-252026-05-07
B637DBC6501HEMO-LYTE CDBC-6502026-05-07
B637DBC7201HEMO-LYTE CDBC-7202026-05-07
B637DBC7601HEMO-LYTE CDBC-7602026-05-07
B637BAC011Di-Chem Hemodialysate AdditiveBAC-012019-09-13
B637BAC021Di-Chem Hemodialysate AdditiveBAC-022019-09-13
B637BAC031Di-Chem Hemodialysate AdditiveBAC-032019-09-13
B637BAC041Di-Chem Hemodialysate AdditiveBAC-042019-09-13
B637BAC201Di-Chem Hemodialysate AdditiveBAC-202019-09-13
B637BAC211Di-Chem Hemodialysate AdditiveBAC-212019-09-13
B637BAC9611Di-Chem Hemodialysate AdditiveBAC-9612019-09-13
B637BAC9621Di-Chem Hemodialysate AdditiveBAC-9622019-09-13
B637BAC9631Di-Chem Hemodialysate AdditiveBAC-9632019-09-13
B637BAC9641Di-Chem Hemodialysate AdditiveBAC-9642019-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103245NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
00842289103252NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
00842289103269NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
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