Device
Dry sodium bicarbonate concentrate cartridge, 45X, 650grams
Manufacturer
Di-Chem, Incorporated
Di-Chem, Incorporated
Model: DBC-650
DI: B637DBC6501
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 sodium bicarbonate concentrate cartridge, 45X, 650grams
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
928a8d9c-b1f4-4029-880b-2cb989098600
Distribution Status:
In Commercial Distribution
DUNS Number:
108677253
Device Count:
8
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
Item #1 - Device ID:
B637DBC6500
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
B637DBC6501
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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:
K202508
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gram
Device Size - Size - @attributes - Value:
650
Device Size - Size Type:
Weight
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Use within 24 hours of priming