Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004201412

FEI Number

3004201412

Entity Name

B. Braun Avitum Saxonia GmbH

City/State/Country

RADEBERG Saxony, DE

Establishment Address

JURI-GAGARIN-STRASSE, 13, RADEBERG Saxony D-01454, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B. BRAUN Avitum AG (Owner Number: 9057188)

Owner / Operator Contact Address

Schwarzenberger Weg 73-79, --, MELSUNGEN, DE-NOTA D-34212, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143482

PMA Number

N/A

All Registered Proprietary Names

Diacap Pro DIACAP ULTRA xevonta

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	2017-08-16
FKQ	System, Dialysate Delivery, Central Multiple Patient	Gastroenterology, Urology	Class 2	876.5820	2006-11-16
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2016-05-05

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN Avitum AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007007791	B. BRAUN AVITUM AG	MELSUNGEN Hesse, DE
9681240	B. Braun Avitum Italy S.p.A.	MIRANDOLA Modena, IT
3014300273	B.Braun Avitum Saxonia GmbH	Wilsdruff Saxony, DE
3002879653	B. Braun Avitum AG	MELSUNGEN Hesse, DE
3004176176	B. Braun Avitum AG	GLANDORF Lower Saxony, 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

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

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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 3004201412. Last updated year: 2026. Please use registration number 3004201412 when referencing this establishment in official correspondence.