FDA.reportPublic FDA data

Insulet Corporation

Matched from indexed company URL: INSULET CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30145855083014585508Insulet Corporation1N2026-01-01100 Nagog Park Acton MA US 01720
30044642283004464228INSULET CORPORATION1N2020-04-25600 Technology Park Dr Suite 200 Billerica MA US 01821
30110184713011018471Insulet Corporation1N2020-04-2514 Progress Road Billerica MA US 01821
30128307203012830720Insulet Corporation1N2020-04-259276 Scranton Rd 4th Floor San Diego CA US 92121

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10385081140003Omnipod - Eros PDM(Personal Diabetes Manager)8005913455xxxx@xxx.com
10385083000152Omnipod Discover - Omnipod Data Management System1-800-591-3455RA@insulet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2255131158183913K251779Omnipod 5 algorithmQJI2025-12-03
2255131712562778K241777SmartAdjust™ TechnologyQJI2024-08-26
2255131068896634K231826Omnipod 5 ACE PumpQFG2023-10-18
2255131026900281K231824SmartBolus CalculatorQRX2023-10-18
2255131919107137K223372Omnipod GO Insulin Delivery DeviceLZG2023-04-24
2255131290580454K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG2021-08-13
1956531163257521K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-10-21
2255121163257521K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-10-21
2255131163257521K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-10-21
618221499635679K191679Omnipod DASH Insulin Management System with interoperable technologyQFG2019-09-20
2255121499635679K191679Omnipod DASH Insulin Management System with interoperable technologyQFG2019-09-20
2255131499635679K191679Omnipod DASH Insulin Management System with interoperable technologyQFG2019-09-20
1956531520185729K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-01-08
2255121520185729K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-01-08
2255131520185729K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG2019-01-08
618221209561111
2255131209561111
2255131468156924
1956531468156924
2255131739818759
618221739818759
618221885928183
618221919733965
2255122041033365
1956532041033365
618222041033365
2255131134994211
2255131260158327
2255131840213319
2255131885928183
2255131919733965
2255132041033365

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZG82023-04-24
QFG42023-10-18
QJI22025-12-03
QRX12023-10-18

PMN#

GUDID#