Search Results
Found 1 results
510(k) Data Aggregation
K Number
K982813Device Name
NATURALYTE, MODEL # 08-4004-1
Manufacturer
Date Cleared
1998-11-06
(87 days)
Product Code
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
KAYBATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population
Device Description
KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.
Ask a Question
Ask a specific question about this device
Page 1 of 1