SDS Bicarb Systems

Basic Information

• Brand Name: SDS Bicarb Systems
• Primary DI: 00817492021174
• Version / Model: SDS,REMOTE,BICARB ONLY,HD,100G,TANK
• Company Name: MAR COR PURIFICATION, INC.
• Labeler DUNS: 019056181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 45d0f35b-8687-4afa-a380-99db70463024

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
FIN	Tank, Holding, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36345	Haemodialysis bicarbonate solution preparation mixer	An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817492021174	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	58	Inch
Depth	60	Inch
Width	102	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 32 – Degrees Fahrenheit