Data / Medical devices / Italy / B. Braun Avitum Italy S.p.A.
B. Braun Avitum Italy S.p.A.: FDA-registered device maker in MIRANDOLA Modena, Italy, 3 510(k) clearances
B. Braun Avitum Italy S.p.A. is registered with the FDA (registration 9681240) in MIRANDOLA Modena, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 2, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9681240
- FEI number
- 3007033498
- Address
- Via XXV Luglio 11, MIRANDOLA Modena, Italy, 41037
- Owner or operator
- B. BRAUN Avitum AG (9057188)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 24, 2007
- Registered through
- 2026
- Brand names listed
- APEX Compounding System Calibration Container, EVA Dual Chamber Mixing Container for use w/ Apex Compounding System, EVA Dual Chamber Mixing Container for use w/ Pinnacle TPN Management Systems, EVA Mixing Container for use with Apex Compounding System, EVA Mixing Container for use with Gravity Transfer, EVA mixing Container for use w/ Pinnacle TPN Management System, High Flow Y-Adapter, Tamper Resistant Clamp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 2, 2015 | K150787 | Universal Spike | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 12, 2008 | K073538 | DUAL CHAMBER TPN CONTAINER | KPE | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 4, 2004 | K041415 | EVA TPN CONTAINER | KPE | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Container, I.V.
- All makers of System/Device, Pharmacy Compounding
Updated December 2, 2015. 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.