Data / Medical devices / Germany / B. Braun Avitum AG
B. Braun Avitum AG: FDA-registered device maker in MELSUNGEN Hesse, Germany, 4 510(k) clearances
B. Braun Avitum AG is registered with the FDA (registration 3002879653) in MELSUNGEN Hesse, Germany. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002879653
- Address
- Am Buschberg 1, MELSUNGEN Hesse, Germany, D-34212
- Owner or operator
- B. BRAUN Avitum AG (9057188)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 29, 2006
- Registered through
- 2026
- Brand names listed
- AQUAbase nX, AQUAbase nX HT, Adimea, Aquaboss® EcoRO Dia I 1050, Aquaboss® EcoRO Dia I 1050 HT, Aquaboss® EcoRO Dia I 1250, Aquaboss® EcoRO Dia I 1250 HT, Aquaboss® EcoRO Dia I 1400 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Contract manufacturer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment | 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 16, 2023 | K223479 | AQUAbase nX | FIP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 25, 2013 | K124059 | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | FIP | Substantially Equivalent | Lauer Membran Wassertechnik GmbH | accessdata.fda.gov |
| February 18, 2010 | K083460 | DIALOG WITH ADIMEA OPTION | KDI | Substantially Equivalent | B. Braun Avitum AG | accessdata.fda.gov |
| June 26, 1998 | K963440 | DIALOG DIALYSIS MACHINE | KDI | Substantially Equivalent | B. Braun Medical AG | accessdata.fda.gov |
Compare with other makers
- All makers of Subsystem, Water Purification
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Pump, Infusion
- All makers of Pump, Infusion, Enteral
- All makers of Medical Device Data System
- All makers of Pump, Infusion, Pca
Updated August 16, 2023. 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.