Premixed Dialysate for Hemodiafiltration

Basic Information

• Brand Name: Premixed Dialysate for Hemodiafiltration
• Primary DI: 09349285000208
• Version / Model: 5B7860
• Catalog Number: 5B7860
• Company Name: Nikkiso Belgium BVBA
• Labeler DUNS: 370482633
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4ba1d9e2-d1c5-4a98-853b-5bd4b7efb9e6
• Distribution End Date: 2017-08-31

Device Description

Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalities that employ hemodiafiltration, such as continuous arteriovenous hemodiafiltration (CAVHD) and Continuous Venous-Venous Hemodiafiltration (CVVHD), when treatment of actue renal failure patients with hypervolemia and uremia requires high solute clearance.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35849	Haemodialysis concentrate	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	19349285000205	GS1	case	2	Not in Commercial Distribution	2017-08-31
Primary	09349285000208	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	5000	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Minimize exposure to heat. Avoid excessive heat. Store at room temperature (25°C/77 °F): brief exposure up to 40 °C (104 °F) does not adversely affect the product
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit