DEVICE: Sharesource Connectivity Platform (05413765565694)
Device Identifier (DI) Information
Sharesource Connectivity Platform
5C9400
Not in Commercial Distribution
5C9400
BAXTER INTERNATIONAL INC.
5C9400
Not in Commercial Distribution
5C9400
BAXTER INTERNATIONAL INC.
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
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FKX | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K151525 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
92ba68ef-e40e-4186-bea4-a6524e588281
July 20, 2023
5
December 15, 2016
July 20, 2023
5
December 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com