Dri-Sate Acid Concentrate Mixes

• • Terminated Z-1869-2018 FDA Class II ·initiated 7 Apr 2018

  A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

• 2 recalls, same reason

  • Terminated Z-0875-2008 FDA Unclassified (pre-2012) ·initiated 3 Dec 2007
  • Terminated Z-0874-2008 FDA Unclassified (pre-2012) ·initiated 3 Dec 2007

  Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

Full name

Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes

510(k) Number

K981003 ↗

FDA Product Code

KPO

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Digital Cuff Pv Gauge

  Class II

  FDA 510(k) K900755 Active Cleared 26 Apr 1990

• Rockwell Medical Supply, LLC. Concentrate Solutions for Acetate Dialysate

  Class II

  FDA 510(k) K973253 Active Cleared 30 Oct 1997

• Nikkiso Infusion Pump Model Pfa-02

  Class II

  FDA 510(k) K861539 Active Cleared 31 Jul 1986

• Robinject

  Class II

  FDA 510(k) K864984 Active Cleared 29 Jun 1987

• Rockwell Medical Supply, LLC. Bicarbonate Solution Concentrates for Bicarbonate Dialysis

  Class II

  FDA 510(k) K971053 Active Cleared 16 Jun 1997

• Rhombo Medical Rhombo-Fill

  Class I

  FDA 510(k) K923942 Active Cleared 24 Mar 1993

See all devices from International Medical Products, Inc. →

• What is the Dri-Sate Acid Concentrate Mixes used for?

  The Dri-Sate Acid Concentrate Mixes are designed as a dialysate concentrate for hemodialysis procedures. They contain salts, sugars, and water to prepare bicarbonate-based dialysate solutions, which help maintain proper electrolyte balance and acid-base regulation during dialysis treatments. This makes them essential for both acute and chronic hemodialysis regimens.

• How is the Dri-Sate Acid Concentrate Mixes supplied, and what form does it come in?

  The Dri-Sate Acid Concentrate Mixes are supplied in two forms: as a powder or as a liquid concentrate. Both forms are intended for on-site mixing with bicarbonate concentrates to create the final dialysate solution. The choice between powder or liquid depends on the clinical workflow and storage requirements of the facility.

• Is the Dri-Sate Acid Concentrate Mixes sterile, and how should it be handled?

  The Dri-Sate Acid Concentrate Mixes are non-sterile and must be mixed with sterile water or bicarbonate solutions in a controlled clinical environment. Proper aseptic techniques are required during preparation to ensure the safety and efficacy of the dialysate solution. Always follow manufacturer guidelines and hemodialysis machine compatibility requirements.

• Are the Dri-Sate Acid Concentrate Mixes intended for single-use or reuse?

  The Dri-Sate Acid Concentrate Mixes are not intended for reuse. Each batch of concentrate must be prepared fresh for use in hemodialysis procedures to ensure proper electrolyte balance and avoid contamination risks. Unexpired concentrates should be stored according to standard pharmaceutical practices until use.

• What storage and handling guidelines should be followed for the Dri-Sate Acid Concentrate Mixes?

  The Dri-Sate Acid Concentrate Mixes should be stored following standard pharmaceutical practices for hemodialysis concentrates. This typically includes keeping them in a clean, dry environment, protected from direct sunlight, and at controlled room temperature unless otherwise specified by the manufacturer. Always check the labeling for expiration dates and storage instructions before use.