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
1022678672
Device Listing 1022678672
Listing Summary
#
Listing key
1022678672
Premarket submission
K162488
Device
Optiflux dialyzer
Applicant
Fresenius Medical Care North America
Product code
KDI
Decision date
2017-04-06
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