Sharesource

Basic Information

• Brand Name: Sharesource
• Primary DI: 25413765545720
• Version / Model: 5CGM01
• Catalog Number: 5CGM01
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-01
• Public Version: 2
• Public Version Date: 2021-05-13
• Public Version Status: Update
• Public Device Record Key: 44f2833a-aa31-43b0-81f6-8ff3f41b7b44

Device Description

Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FKX	System, peritoneal, automatic delivery	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41049	Nephrology information system application software	An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of nephrology services. It is used by renal professionals to track disease progression, manage co-morbidities, and prepare patients for renal therapies such as haemodialysis, peritoneal dialysis, and transplant. It is typically installed into a dedicated information system for nephrology or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25413765545720	GS1

Customer Contacts

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