Sharesource Connectivity Platform 5C9400

GUDID 15413765565691

Sharesourece 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 Amia APD System.

BAXTER INTERNATIONAL INC.

Nephrology information system application software
Primary Device ID15413765565691
NIH Device Record Key41ab0569-fcfb-4d3a-8e5e-3dfb19db58f5
Commercial Distribution Discontinuation2019-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSharesource Connectivity Platform
Version Model Number5C9400
Catalog Number5C9400
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115413765565691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FKXSystem, peritoneal, automatic delivery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-17
Device Publish Date2017-12-02

On-Brand Devices [Sharesource Connectivity Platform]

00085412529776Sharesourece is a web-based connectivity platform that allows authorized users, including nephro
05413765565694Sharesourece is a web-based connectivity platform that allows authorized users, including nephro
25413765565698Sharesource is a web-based connectivity platform that allows authorized users, including nephrol
15413765565691Sharesourece is a web-based connectivity platform that allows authorized users, including nephro

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