GC-BC-01, GC-BC-02, GC-BC-03 Bicarbonate Dry Packs
510(k) K901472
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901472 | Date27 Jul 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPO
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The GC-BC-01, GC-BC-02, and GC-BC-03 Bicarbonate Dry Packs are dry bicarbonate buffer packs designed as a component of dialysate concentrate for hemodialysis. These packs provide a powdered formulation intended to dissolve and prepare a carbonate-bicarbonate buffer solution for medical use.
These dry packs are supplied as single-use, non-sterile items and are classified as Class II medical devices under FDA regulation 876.5820. They are intended for use in hemodialysis procedures, where the buffer aids in maintaining electrolyte balance during treatment. Each pack is labeled with a distinct model number for identification and must be stored in a dry environment to preserve integrity.
Other devices from Granite Chemical Co., Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these bicarbonate dry packs intended for direct patient administration, or are they meant to be mixed into another solution before use?
These GC-BC-01, GC-BC-02, and GC-BC-03 Bicarbonate Dry Packs are designed as a component of dialysate concentrate for hemodialysis. They must be dissolved and prepared into a carbonate-bicarbonate buffer solution before being combined with other dialysate ingredients. They are not meant for direct patient administration but rather to help maintain electrolyte balance during hemodialysis treatment.
How should these dry packs be stored, and why is this important?
The GC-BC dry packs must be stored in a dry environment to preserve their integrity. Since they are powdered formulations, exposure to moisture could compromise their effectiveness or lead to clumping, making them difficult to dissolve properly when preparing the dialysate concentrate.
Are these bicarbonate dry packs reusable, or are they intended for single-use only?
These GC-BC-01, GC-BC-02, and GC-BC-03 Bicarbonate Dry Packs are explicitly labeled as single-use items. After dissolving one pack to prepare the buffer solution, the remaining powder should not be reused, as this could introduce contamination risks or reduce the reliability of the dialysate concentrate.
What distinguishes the three model numbers (GC-BC-01, GC-BC-02, GC-BC-03) from each other?
The three model numbers (GC-BC-01, GC-BC-02, GC-BC-03) are distinctly labeled for identification purposes, though the provided data does not specify exact differences in formulation or concentration. Typically, such variations in dry packs could relate to bicarbonate strength or buffering capacity, but the manufacturer’s labeling or accompanying documentation would provide precise details for clinical use.
What regulatory pathway was followed for FDA clearance of these bicarbonate dry packs?
The GC-BC-01, GC-BC-02, and GC-BC-03 Bicarbonate Dry Packs were cleared through the FDA 510(k) process, specifically under a Traditional 510(k) submission. The decision was classified as *Substantially Equivalent (SESE)*, meaning the device was determined to have the same intended use and technological characteristics as a legally marketed predicate device. The review was conducted under FDA regulation 876.5820 and involved the Gastroenterology/Urology (GU) Advisory Committee.