FDA Registration Active 🇩🇪 Germany

Pabst Transport GmbH & Co. KG

Reg #: 3035708507 · FEI: 3035708507 · Expires 2026
Products
8
Proprietary Names
14
Establishment Types
1
Classifications
8

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Registration Details

Registration Name
Pabst Transport GmbH & Co. KG
Registration Number
3035708507
FEI Number
3035708507
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Industriestrasse 15
City
Gochsheim Bavaria
Country
DE

Regulatory Submissions

510(k) Number
K220721

Owner / Operator

Firm Name
FRESENIUS MEDICAL CARE
Operator Number
8010838
Address
ELSE KROENER-STRASSE 1, --
City
BAD HOMBURG
State
Hesse
Postal Code
D-61352
Country
DE

US Agent

Business Name
VP Regulatory Affairs NA
Contact Name
Denise Oppermann
Address
920 Winter St
City
North Waltham
State
MA
ZIP
02451
Country
US
Phone
781 9969103

Products

Device Name Product Code
Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
Subsystem, Water Purification FIP
Set, Administration, For Peritoneal Dialysis, Disposable KDJ
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ
Disinfectant, Dialysate Delivery System NII
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
Accessories, Blood Circuit, Hemodialysis KOC

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 5008X Hemodialysis System AquaBplus & AquaBplus B2 & AquaBplus HF AquaBplus & AquaBplus B2 AquaBplus & AquaBplus HF AquaA

Establishment Types

Export Device to the United States But Perform No Other Operation on Device