FDA.reportPublic FDA data

Infutronix

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115819063011581906INFUTRONIX LLC1N2020-04-25177 PINE ST Natick MA US 01760

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1831121624226544K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)FRN2016-08-30
1831121480680904K140783HALO AMBULATORY INFUSION SYSTEMFRN2014-10-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN22016-08-30

GUDID#