The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Freeflex+ Transfer Adapter.
| Device ID | K212445 |
| 510k Number | K212445 |
| Device Name: | Freeflex+ Transfer Adapter |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Fresenius Kabi AG Bad Homburg, DE 61346 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, IL 60047 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2022-06-01 |