Device
Dry acid concentrate for bicarbonate dialysis, 2.0Ca / 3.0K, 45X, 25 Gallon
Manufacturer
Di-Chem, Incorporated
Di-Chem, Incorporated
Model: C25-203-21
DI: B637C25203210
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Dry acid concentrate for bicarbonate dialysis, 2.0Ca / 3.0K, 45X, 25 Gallon
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f71e00b9-f0ec-494f-9c2f-a2fed0d80d8e
Distribution Status:
In Commercial Distribution
DUNS Number:
108677253
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B637C25203210
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 35849
Name: Haemodialysis concentrate
Definition:
A 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.
FDA Product Codes
KPO
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Premarket Submissions
Submission Number:
K171015
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gallon
Device Size - Size - @attributes - Value:
25
Device Size - Size Type:
Total Volume
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Use within 30 days of mixing