B. Braun Avitum AG

FDA Device Registration & Listing · MELSUNGEN Hesse, DE · Registration 3002879653

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
3002879653
FEI Number
3002879653
Entity Name
B. Braun Avitum AG
City/State/Country
MELSUNGEN Hesse, DE
Establishment Address
Am Buschberg 1, MELSUNGEN Hesse D-34212, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
N
Expiration Date (Year)
2026
510(k) Number
K963440
PMA Number
N/A

All Registered Proprietary Names

Dialog+ Adimea Dialog+ ABPM Cuff Infusomat Space Aquaboss® EcoRO Dia I 700 HT Aquaboss® EcoRO Dia I 2800 Aquaboss® EcoRO Dia II 1400 HT Aquaboss® EcoRO Dia II 900 Aquaboss® EcoRO Dia II 2800 HT Aquaboss® EcoRO Dia II 1800 Aquaboss® EcoRO Dia I 2450 HT Aquaboss® EcoRO Dia II 1050 Aquaboss® EcoRO Dia II 900 HT Aquaboss® EcoRO Dia II 2100 Aquaboss® EcoRO Dia I 1400 Aquaboss® EcoRO Dia I 700 Aquaboss® EcoRO Dia I 2100 Aquaboss® EcoRO Dia I 3600 Aquaboss® EcoRO Dia II 1400 Aquaboss® EcoRO Dia II 1050 HT Aquaboss® EcoRO Dia I 1250 Aquaboss® EcoRO Dia I 3600 HT Aquaboss® EcoRO Dia II 700 HT Aquaboss® EcoRO Dia II 2100 HT Aquaboss® EcoRO Dia II 2800 Aquaboss® EcoRO Dia I 2450 Aquaboss® EcoRO Dia II 2450 Aquaboss® EcoRO Dia I 1050 Aquaboss® EcoRO Dia I 2100 HT Aquaboss® EcoRO Dia II 2450 HT Aquaboss® EcoRO Dia I 1800 HT Aquaboss® EcoRO Dia II 3600 Aquaboss® EcoRO Dia I 1400 HT Aquaboss® EcoRO Dia II 1800 HT Aquaboss® EcoRO Dia I 2800 HT Aquaboss® EcoRO Dia I 900 HT Aquaboss® EcoRO Dia I 1800 Aquaboss® EcoRO Dia I 1250 HT Aquaboss® EcoRO Dia II 700 Aquaboss® EcoRO Dia I 1050 HT Aquaboss® EcoRO Dia II 3600 HT Aquaboss® EcoRO Dia II 1250 AQUAbase nX HT AQUAbase nX Perfusor Space Perfusor Perfusor Space Dialog+ ABPM Cuff Dialog+

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 2011-04-27
FRN Pump, Infusion General Hospital Class 2 880.5725 2015-10-19
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-01-30
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2023-09-07
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-01-28
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2014-01-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-07-18
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-07-18
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2006-11-29

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
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
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30
K840616 Advanced Bio Systems, Inc. MINI-PUMP U-100 1984-03-30

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002879653. Last updated year: 2026. Please use registration number 3002879653 when referencing this establishment in official correspondence.
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