Sodium Bicarbonate for Hemodialysis

Sodium Bicarbonate for Hemodialysis
BiCart - 1250

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.

• Weight: 1250 Gram

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KPO

Device Name: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5820

Third Party Flag: N

Medical Specialty: GU

Device Id: 37332414110575

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07332414110574

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 07332414110574

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A