Electronic Instructions for Use and Distributor Information
For medical devices, Fresenius Kabi AG may provide electronic instructions for use instead of or in addition to paper copies where allowed or required.
Available Websites for eIFU
There are currently two Fresenius Kabi websites that provide electronic instructions for use (eIFU) for the MedTech portfolio.
- Transfusion Medicine and Cell Therapies: eifu.fresenius-kabi.com
- Infusion and Nutrition Systems: ifu.fresenius-kabi.com
You should confirm which website has the appropriate eIFU by looking at the device labeling. If the instructions may be accessed online, the Fresenius Kabi website URL will be listed next to the "Consult Instruction for Use" symbol.
When using Fresenius Kabi AG devices, licensed Medical Healthcare Professionals should keep product IFUs readily available for operator's reference during any procedure.
Additional Documentation
For Infusion and Nutrition Systems products with eIFU distributed on ifu.fresenius-kabi.com, you will also find additional documentation including:
- Summary of Safety and Clinical Performance (SSCP), as long as EUDAMED is not publicly available.
- ISO 13485/9001 Certificates
- Declaration of Conformity (DoC)
- Certificates of Quality (CoQ)
Contact Information for printed copies
For Infusion and Nutrition Systems using ifu.fresenius-kabi.com
If you have difficulties accessing documents or would like to request a printed copy at no extra cost, please contact Fresenius Kabi AG and reference the website revision number, such as “eIFU-00 2021-02”:
Fresenius Kabi MedTech
Else-Kröner-Str. 1
61352 Bad Homburg, Germany
Phone: +49 (0) 6172 / 686-0
Website: www.fresenius-kabi.com.
For Transfusion Medicine and Cell Therapies using eifu.fresenius-kabi.com
Please follow the instructions on the site to request printed copies of documents.
Important Note
Specifications in IFUs, manuals and other documentation may change for different versions of a product. Consequently, using the incorrect version of an IFU, manual or other documentation may lead to erroneous results. Please be sure that you obtain the correct document and version for the Fresenius Kabi AG product you are using. Your use of the Fresenius Kabi eIFU sites constitutes your acknowledgment that you are responsible for obtaining and using the correct version of the document that corresponds to the version of the product you are using and that Fresenius Kabi AG will bear no responsibility or liability for your failure to do so. If you have any question about which version of an IFU or other document to use, please contact your local Fresenius Kabi AG representative.