Dry Acid Dissolution Unit

Basic Information

• Brand Name: Dry Acid Dissolution Unit
• Primary DI: 00840861100996
• Version / Model: 160147
• Company Name: Fresenius Usa, Inc.
• Labeler DUNS: 076594100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1eb95446-0553-4bb1-bd10-50554625ec84

Device Description

132 Gallon

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
36342	Haemodialysis system fluid mixer	An electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840861100996	GS1

Customer Contacts

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