Optum Distribution Center, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094569233009456923Optum Distribution Center, LLC1N2026-01-01877 Franklin Rd # 205 Marietta GA US 30067

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1824781585917306K213744Avoset Infusion Pump SystemFRN2023-03-10
1824781072755909K210687CONTOURĀ® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
1824781255572153K193407ContourĀ® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
1824781124829450K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)FRN2016-08-30
1824781887735585K141160A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITORDXN2014-10-07
1824781474778957K113159U-RIGHT TD-1240 THERMOMETERFLL2012-01-06
1824781335843501K050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERSFRN2005-11-23
1824781063283560K043217A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORDXN2005-03-03
1824781008531493
1824781331057129
1824781899333820

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN32023-03-10
NBW22021-12-23
DXN22014-10-07
FLL12012-01-06

GUDID#