Insulet Corp

FDA Filings

This page includes the latest FDA filings for Insulet Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQPODDDUNS 051334402
FDA Registration(s)
Registration Number3004464228
FEI Number3004464228
NameINSULET CORPORATION
Owner & OperatorINSULET CORPORATION
Contact Address100 Nagog Park --
Acton MA 01720 US
Official Correspondent
  • Michael Spears
  • x-978-6007451-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address600 Technology Park Dr Suite 200
Billerica, MA 01821 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3012830720
FEI Number3012830720
NameInsulet Corporation
Owner & OperatorINSULET CORPORATION
Contact Address100 Nagog Park --
Acton MA 01720 US
Official Correspondent
  • Michael Spears
  • x-978-6007451-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9276 Scranton Rd 4th Floor
San Diego, CA 92121 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only



Registration Number3014585508
FEI Number3014585508
NameInsulet Corporation
Owner & OperatorINSULET CORPORATION
Contact Address100 Nagog Park --
Acton MA 01720 US
Official Correspondent
  • Michael Spears
  • x-978-6007451-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address100 Nagog Park
Acton, MA 01720 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



Registration Number3011018471
FEI Number3011018471
NameInsulet Corporation
Owner & OperatorINSULET CORPORATION
Contact Address100 Nagog Park --
Acton MA 01720 US
Official Correspondent
  • Michael Spears
  • x-978-6007451-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14 Progress Road
Billerica, MA 01821 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Insulet Corporation
Omnipod 5 Controller APP 2024-07-30
Insulet Corporation
Omnipod DASH Pod 2024-07-29
Insulet Corporation
Omnipod 18900-5A2024-07-29
Insulet Corporation
Omnipod 5 Controller APP 2024-07-29
Insulet Corporation
Omnipod 5 Starter Kit 2024-07-29
Insulet Corporation
Omnipod 14500-5A2024-07-29
INSULET CORPORATION
Omnipod 5 Pod 2024-05-13
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 40U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 35U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 30U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 25U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 20U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 15U/day 2023-08-28
INSULET CORPORATION
Omnipod Go Insulin Delivery Device 10U/day POD 2023-08-28
Insulet Corporation
SmartBolus Calculator2022-08-19
Insulet Corporation
SmartAdjust(TM) Technology2022-08-19
INSULET CORPORATION
Omnipod 5 Pod 2022-03-07
INSULET CORPORATION
Omnipod 5 Controller SKT-H001-G-X92022-03-07
INSULET CORPORATION
Omnipod 5 Controller APP 2022-03-07
Insulet Corporation
SmartAdjust Technology2022-01-27
Insulet Corporation
Omnipod 5 SmartBolus Calculator2022-01-27
Insulet Corporation
Omnipod 5 ACE Pump (Pod)2022-01-27
Insulet Corporation
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System2021-08-13
INSULET CORPORATION
Omnipod (Dash) View APP 182392021-03-01
INSULET CORPORATION
Omnipod (Dash) Display App. 182392021-03-01
INSULET CORPORATION
Omnipod 191912021-02-22
INSULET CORPORATION
Omnipod 140002021-02-22
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod DASH Insulin Management System2019-12-05
Insulet Corporation
Omnipod Insulin Management System, Omnipod DASH Insulin Management System2019-10-21
Insulet Corporation
Omnipod DASH Insulin Management System With Interoperable Technology2019-09-20
Insulet Corporation
Omnipod DASH VIEW Application2019-07-18
Insulet Corporation
Omnipod DASH VIEW Application2019-07-18
Insulet Corporation
Omnipod DASH DISPLAY Application2019-07-18
Insulet Corporation
Omnipod DASH DISPLAY Application2019-07-18
INSULET CORPORATION
Omnipod PodPals 2019-07-09
INSULET CORPORATION
Omnipod DASH Starter Kit SKT -USA 1-DOO 1-MG-ENG2019-06-06
Insulet Corporation
PodPals Adhesive Overlay2019-05-21
Insulet Corporation
Amgen Adhesive Overlay2019-05-21
Insulet Corporation
Omnipod Insulin Management System, Omnipod DASH Insulin Management System2019-01-08
Insulet Corporation
Omnipod DASH Insulin Management System2018-06-01
Insulet Corporation
Amgen Neulasta On Body Injector2018-01-26
INSULET CORPORATION
Amgen Neulasta On Body Injector2018-01-26
INSULET CORPORATION
OmniPod Insulin Management System2017-04-18
INSULET CORPORATION
OmniPod Insulin Management System2016-04-27
Insulet Corporation
On-body Injector for Neulasta2015-02-20
INSULET CORPORATION
On-body Injector for Neulasta2015-02-20
Insulet Corporation
On-body Injector for Neulasta2015-02-20
INSULET CORPORATION
On-body Injector for Neulasta2015-02-20
INSULET CORPORATION
OMNIPOD INSULIN MANAGEMENT SYSTEM2014-11-13
INSULET CORPORATION
OMNIPOD INSULIN MANAGEMENT SYSTEM2013-08-29
INSULET CORPORATION
OMNIPOD INSULIN MANAGMENT SYSTEM2012-12-07
Insulet Corporation
Omnipod DASH Insulin Management System2012-01-31
Insulet Corporation
Omnipod DASH Insulin Management System2012-01-31
Insulet Corporation
Omnipod DASH Insulin Management System2012-01-31
Insulet Corporation
OmniPod Insulin Management System2012-01-31
Insulet Corporation
OmniPod Insulin Management System2012-01-31
Insulet Corporation
OmniPod Insulin Management System2012-01-31
INSULET CORPORATION
Omnipod DASH Insulin Management System2012-01-31
INSULET CORPORATION
OmniPod Insulin Management System2012-01-31
Insulet Corporation
Infusion Pump for Fertility Drug Delivery2012-01-31
INSULET CORPORATION
Infusion Pump for Fertility Drug Delivery2012-01-31
INSULET CORPORATION
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS2011-12-15
INSULET CORPORATION
IXL-II DIABETES MANAGEMENT SYSTEM2005-01-03
INSULET CORP.
IXL DIABETES MANAGEMENT SYSTEM2003-12-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092623350Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSULIN PUMP SYSTEM WITH SILVER BATTERY SO# 104N69942-104N69946 PI# 105549756-105549760 PO# P0066020 P N# ISLH-95N-PT-000084 QTY# 17355 PCS20 PKG
2020092614069Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts165 CARTONS PACKED ON 11 PALLETS MEDICAL EQUIPMENT HS-CODE 90183110 . . .165 PKG
2020092623402Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSULIN PUMP SYSTEM WITH SILVER BATTERY SO# 104N69947-104N69951 PI# 105549761-105549765 PO# P0066017 P0066020 P N# ISLH-95N-40159MUFG ISLH-95N-PT-00008420 PKG
2020092611441Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyTRAY HS 4823700000999 5 PLTS STC 92 CTNS TRANSHIPMENT FROM SHENZHEN, CHINA, TO BOSTON, MA VIA HONG KONG BY TRUCK92 CTN
2020092623330Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSULIN PUMP SYSTEM WITH SILVER BATTERY SO# 104N69936 104N69938-104N69941 PI# 105549751-105549755 PO# P0066022 P N# ISLH-95N-PT-00011620 PKG
2020092412014Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts165 CARTONS PACKED ON 11 PALLETS MEDICAL EQUIPMENT HS-CODE 90183110 . . .165 PKG
202009225073Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSULIN PUMP SYSTEM WITH SILVER BATTERY SO# 104N69811-104N69815 PI# 105543591-105543595 PO# P0066022 P N# ISLH-95N-PT-000116 QTY# 34704 PCS40 PKG
202009225073Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyINSULIN PUMP SYSTEM WITH SILVER BATTERY SO# 104N69806-104N69810 PI# 105543586-105543590 PO# P0066022 P N# ISLH-95N-PT-00011 QTY# 34703 PCS40 PKG
2020092281Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyNUU SMARTPHONE (PACKED WITH LITHIUM ION BATTERIES) HS CODE 85171200 POLYBAG FOR SMARTPHONE HS CODE 39232110 (18 PLASTIC PALLETS STC629 CTN

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