Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1458191945
Device Listing 1458191945
Listing Summary
#
Listing key
1458191945
Premarket submission
K192707
Device
Optiflux F180NR Dialyzer
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
KDI
Decision date
2020-09-21
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
17126
1225714
3001451489
Fresenius Medical Care Renal Therapies Group, LLC
1
Y
2026-01-01
920 WINTER STREET Waltham MA US 02451
17131
1713747
1713747
Fresenius USA Manufacturing, Inc.
1
N
2026-01-01
475 WEST 13TH ST. Ogden UT US 84404