Data / Medical devices / Germany / B. Braun Avitum AG
B. Braun Avitum AG: FDA-registered device maker in GLANDORF Lower Saxony, Germany, 7 510(k) clearances
B. Braun Avitum AG is registered with the FDA (registration 3004176176) in GLANDORF Lower Saxony, Germany. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 11, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004176176
- Address
- Kattenvenner STR. 32, GLANDORF Lower Saxony, Germany, DE-49219
- Owner or operator
- B. BRAUN Avitum AG (9057188)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 16, 2006
- Registered through
- 2026
- Brand names listed
- B Braun Modified Bicarbonate Dialysate, B. Braun Bicarbonate Dialysate, Citric Acid, Citric Acid 50%, DIACAP ULTRA, Diacap Pro, NxtStage Pureflow Solution, PureFlow B Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| System, Dialysate Delivery, Central Multiple Patient | FKQ | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2017 | K170574 | Diacap Pro Dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| March 1, 2016 | K143482 | xevonta dialyzer | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| April 25, 2011 | K102194 | SOLCART B | KPO | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| January 29, 2008 | K072760 | SOLCART B | KPO | Substantially Equivalent | B. Braun Medizintechnologie GmbH | accessdata.fda.gov |
| June 9, 2006 | K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | FKQ | Substantially Equivalent | B. Braun Medizintechnologie GmbH | accessdata.fda.gov |
| November 9, 2005 | K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE | KPO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 27, 2004 | K041683 | B. BRAUN BICARBONATE DIALYSATE | KPO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Disinfectant, Medical Devices
Updated August 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.