Pabst Transport GmbH & Co. KG

FDA Device Registration & Listing · Gochsheim Bavaria, DE · Registration 3035708507

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
3035708507
FEI Number
3035708507
Entity Name
Pabst Transport GmbH & Co. KG
City/State/Country
Gochsheim Bavaria, DE
Establishment Address
Industriestrasse 15, Gochsheim Bavaria 97469, DE
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
K162716
PMA Number
N/A

All Registered Proprietary Names

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 AquaC UNO H Fresenius Sterile Stay Safe Cap Novalung DIASAFEplusUS AquaBplus AquaB LITE pureFLOW 400, pureFLOW 401, pureFLOW 402, pureFLOW 406 bibag

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 2023-07-28
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2015-04-09
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-10-27
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2017-03-28
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Cardiovascular Class 2 870.4100 2022-07-21
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
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-07-08
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2024-05-08
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2018-06-28

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
3043014136 GXO Logistics H France Andrezieux-Boutheon Loire, FR
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
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 3035708507. Last updated year: 2026. Please use registration number 3035708507 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.