Duosol™ Bicarb 35 Dialysate K0/Ca3 2X5000 ML (4551)

Duosol™ Bicarb 35 Dialysate K0/Ca3 2X5000 ML (4551)
B.BRAUN - 4551

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.

• HCO3- concentration (mEq/L) : 35.000 MEQ
• Ca++ concentration (mEq/L) : 3.000 MEQ
• K+ concentration (mEq/L) : 0.000 MEQ
• Volume : 5000.000 ML

Device Sterile: True

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: 04039239085089

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

Device Id: 04039239084990

Device Type: Unit of Use

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