Freeflex+ Transfer Adapter

Set, I.v. Fluid Transfer

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Freeflex+ Transfer Adapter.

Pre-market Notification Details

Device IDK212445
510k NumberK212445
Device Name:Freeflex+ Transfer Adapter
ClassificationSet, I.v. Fluid Transfer
Applicant Fresenius Kabi AG Bad Homburg,  DE 61346
ContactKeith Dunn
CorrespondentKeith Dunn
Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich,  IL  60047
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-05
Decision Date2022-06-01

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