FDA.reportPublic FDA data

Vantive Health GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30339031553033903155Vantive Health GmbH1N2026-01-01Thurgauerstrasse 130 Glattpark (Opfikon) Zurich CH 8152

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07332414088316BiCart - Sodium Bicarbonate for Hemodialysis+1(800)553-6898Us.RENAL.Support.Co@vantive.com
07332414200183Revaclear - REVACLEAR 500 dialyzer is indicated for the treatment of chronic or acute renal failure.+1(800)284-4060US.customerservice@vantive.com
07332414201340PRISMAFLEX SET M100 - The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.+1(800)240-4060US.customerservice@vantive.com
07332414201364PRISMAFLEX SET M150 - The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.+1(800)240-4060US.customerservice@vantive.com
07332414201388PRISMAFLEX SET M60 - The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.+1(800)240-4060US.customerservice@vantive.com
07332414202309TherMax - The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.888-736-2543uscanmedinfo@vantive.com
07332414202491Homechoice Claria APD Cycler - Homechoice Claria APD system is intended for Automated Peritoneal Dialysis therapy for treating patients with end-stage renal disease in clinical and home settings(800)284-4060US.customerservice@vantive.com
57332414206296Sharesource Connectivity Platform for Use with the Homechoice Claria APD System - Sharesource Claria 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 Homechoice Claria APD System.+1(800)284-4060US.customerservice@vantive.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3458981019299460K190910PrisMax System Version 2KDI2019-07-25
3458981438175032K082758PRISMAFLO IIKOC2008-12-19
3458981590359294

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI12019-07-25
KOC12008-12-19

GUDID#