Sharesource - Sharesource is a web-based connectivity platform - BAXTER HEALTHCARE CORPORATION

Duns Number:005083209

Device Description: Sharesource is a web-based connectivity platform that allows authorized users, including n 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.

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More Product Details

Catalog Number

5CGM01

Brand Name

Sharesource

Version/Model Number

5CGM01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FKX

Product Code Name

System, peritoneal, automatic delivery

Device Record Status

Public Device Record Key

44f2833a-aa31-43b0-81f6-8ff3f41b7b44

Public Version Date

May 13, 2021

Public Version Number

2

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAXTER HEALTHCARE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 101
3 A medical device with high risk that requires premarket approval 19