Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010182

FEI Number

3002807204

Entity Name

GAMBRO INDUSTRIES

City/State/Country

MEYZIEU CEDEX Rhone, FR

Establishment Address

7, AV. LIONEL TERRAY, B.P. 126, MEYZIEU CEDEX Rhone 69883, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Vantive US Healthcare LLC (Owner Number: 9038727)

Owner / Operator Contact Address

510 Lake Cook Road, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P830063

All Registered Proprietary Names

PRISMAFLEX HF 1000 SET PRISMAFLEX HF 1400 SET PRISMAFLEX MONITOR PRISMAFLEX M60 SET PRISMAFLEX M100 SET DIACLEAR Prismaflex ST set (ST60/ST100/ST150 sets) PRISMAFLEX TPE 2000 SET PRISMA TPE 2000 SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2008-05-18
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2006-04-06
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2010-02-16
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2022-04-05
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma	Unknown	Class 3	N/A	2006-11-22

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: Vantive US Healthcare LLC Email: jennifer.masek.little@vantive.com Phone: (815) 3548549

Related Public Records

Same Entity

Vantive US Healthcare LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610725	Vantive Manufacturing Limited	CASTLEBAR, COUNTY MAYO Connaught, IE
9612168	Vantive Manufacturing Limited	SWINFORD Mayo, IE
3030306055	Vantive US Healthcare LLC	Deerfield, IL, US
3006755813	Bieffe Medital Manufacturing Oued Ellil Tunisia	Oued Ellil Manouba, TN
3033903155	Vantive Health GmbH	Glattpark (Opfikon) Zurich, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K110578	Mar Cor Purification, Inc.	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	2011-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010182. Last updated year: 2026. Please use registration number 8010182 when referencing this establishment in official correspondence.