HEMO-LYTE C

Primary DI
B637DBC7601
Brand
HEMO-LYTE C
Company
Di-Chem, Incorporated
Model
DBC-760
Device description
Dry sodium bicarbonate concentrate cartridge, 45X, 760grams
Published
2026-05-07
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202508000Hemo-Lyte C CartridgeDi-Chem, Inc.2022-08-12KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B637DBC7601PrimaryHIBCC0
B637DBC7600Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight760Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Use within 24 hours of priming

Contacts#

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

Regulatory Flags#

DUNS number
108677253
Device count
8
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
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
B637BAC9651Di-Chem Hemodialysate AdditiveBAC-9652019-09-13

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