Skip to content

Sharesource Connectivity Platform for Use with the Homechoice Claria APD System 5CGM01

by Vantive Health GmbH

Ref 5CGM01

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number57332414206296 UDI-DI Date22 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number7332414VA0001012N Basic UDI-DI 57332414206296UDI-DIDate21 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0409-2026 FDA Class II initiated 28 Aug 2025

    Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

    • Ongoing Z-1316-2023 FDA Class II initiated 22 Feb 2023

    The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (also referred as Sharesource Claria (5CGM01)) EUDAMED
Sharesource Connectivity Platform for Use with the Homechoice Claria APD System GUDID
Generic Name
Nephrology information system application software
Model / Reference
5CGM01
Primary DI / UDI-DI
57332414206296
Basic UDI-DI
7332414VA0001012N
510(k) Number
FDA Product Code
FKX
EMDN Code
Z12090192 Peritoneal dialysis instruments - medical device software
GMDN Term
Nephrology information system application software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5630
Medical Purpose
Sharesource Claria is intended to remotely communicate, monitor, and manage treatment parameters from compatible dialysis instruments used for patients undergoing Peritoneal dialysis
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K201867)

Other devices from Vantive Health GmbH

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No