Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004176176

FEI Number

3004176176

Entity Name

B. Braun Avitum AG

City/State/Country

GLANDORF Lower Saxony, DE

Establishment Address

KATTENVENNER STR. 32, GLANDORF Lower Saxony DE-49219, DE

Establishment Type(s)

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

B Braun Modified Bicarbonate Dialysate Solcart B Solcart B 760g Solcart B 650g Citric Acid 50% Citric Acid B. Braun Bicarbonate Dialysate Solcart B 1100g DIACAP ULTRA PureFlow B Solution NxtStage Pureflow Solution xevonta

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	2008-05-12
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2008-03-17
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2010-10-11
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2008-05-14
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2008-05-12
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2011-05-09
FKQ	System, Dialysate Delivery, Central Multiple Patient	Gastroenterology, Urology	Class 2	876.5820	2006-11-16
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2010-10-11
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
3004201412	B. Braun Avitum Saxonia GmbH	RADEBERG Saxony, DE
3014300273	B.Braun Avitum Saxonia GmbH	Wilsdruff Saxony, DE
3002879653	B. Braun Avitum AG	MELSUNGEN 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

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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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 3004176176. Last updated year: 2026. Please use registration number 3004176176 when referencing this establishment in official correspondence.