AccessGUDID - DEVICE: Sharesource Connectivity Platform (05413765565694)

GUDID

Device Identifier (DI) Information

Brand Name: Sharesource Connectivity Platform
Version or Model: 5C9400
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5C9400
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 05413765565694
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
FKX	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92ba68ef-e40e-4186-bea4-a6524e588281
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016