GXO Logistics H France

FDA Device Registration & Listing · Andrezieux-Boutheon Loire, FR · Registration 3043014136

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043014136
FEI Number
3043014136
Entity Name
GXO Logistics H France
City/State/Country
Andrezieux-Boutheon Loire, FR
Establishment Address
500 Rue Colonel Louis Lemaire, Andrezieux-Boutheon Loire 42160, FR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
FRESENIUS MEDICAL CARE (Owner Number: 8010838)
Owner / Operator Contact Address
ELSE KROENER-STRASSE 1, --, BAD HOMBURG, DE-HE D-61352, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243505
PMA Number
N/A

All Registered Proprietary Names

pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 DIASAFEplusUS Bicarby Dialysate FX CorAL Dialyzers 5008X Hemodialysis System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2024-05-08
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2024-02-15
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-02-15
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2024-02-15
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-02-15
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2025-11-26
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-11-26
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-06-10
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2025-06-10
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2025-06-10
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-06-10
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Denise Oppermann Business: VP Regulatory Affairs NA Email: denise.m.oppermann@freseniusmedicalcare.com Phone: (781) 9969103

Related Public Records

Same Entity

FRESENIUS MEDICAL CARE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3035708507 Pabst Transport GmbH & Co. KG Gochsheim Bavaria, DE
9611823 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ST. WENDEL Saarland, DE
3016096143 TST GmbH Gernsheim Hesse, DE

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
2431908 EDLAW PHARMACEUTICALS, INC. E Farmingdale, NY, US
9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3027241826 RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. El Marques Queretaro, MX
1225714 Fresenius Medical Care Renal Therapies Group, LLC Waltham, MA, US
1528807 Nipro Renal Solutions USA, Corporation LEWISBERRY, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043014136. Last updated year: 2026. Please use registration number 3043014136 when referencing this establishment in official correspondence.
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