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Company-Registration
1202960113
Device Listing 1202960113
Listing Summary
#
Listing key
1202960113
Premarket submission
K183311
Device
Ivenix Infusion System (IIS)
Applicant
Ivenix, Inc.
Product code
FRN
Decision date
2019-06-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
175374
9612051
3002806457
FENWAL INTERNATIONAL, INC.
1
N
2026-01-01
CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C. HAINA San Cristobal DO --
179717
3005778453
3005778453
FRESENIUS KABI WARRENDALE
1
N
2026-01-01
770 Commonwealth Dr WARRENDALE PA US 15086
305423
3014732157
3014732157
Fresenius Kabi USA, LLC
1
N
2026-01-01
50 High Street Suite 50 North Andover MA US 01845