FDA Registration
Active
🇺🇸 United States
Insulet Corporation
Reg #: 3014585508
·
FEI: 3014585508
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
5
Classifications
10
Registration Details
- Registration Name
- Insulet Corporation
- Registration Number
- 3014585508
- FEI Number
- 3014585508
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Nagog Park
- City
- Acton
- State
- MA
- ZIP
- 01720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231826
Owner / Operator
- Firm Name
- INSULET CORPORATION
- Operator Number
- 9056196
- Address
- 100 Nagog Park, --
- City
- Acton
- State
- MA
- Postal Code
- 01720
- Country
- US
- Correspondent
- Chuck Medovich
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-05-21 |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | Class 1 | Clinical Chemistry | No | 2023-11-30 |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | Class 2 | Clinical Chemistry | No | 2024-07-09 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2015-02-20 |
| Interoperable Automated Glycemic Controller | QJI | Class 2 | Clinical Chemistry | No | 2024-09-09 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2023-05-16 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2021-11-04 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2021-11-04 |
| Continuous Glucose Monitor Informed Insulin Dose Calculator | QRX | Class 2 | Clinical Chemistry | No | 2024-07-09 |
| Injector, Pen | NSC | Class 2 | General Hospital | No | 2015-02-20 |
Proprietary Names
PodPals Adhesive Overlay
Amgen Adhesive Overlay
Omnipod Discover
Omnipod 5 Pod
On-body Injector for Neulasta
Omnipod 5 SmartAdjust
Omnipod GO Insulin Delivery Device, 5-Pack 10U
Omnipod GO Insulin Delivery Device, 5-Pack 35U
Omnipod GO Insulin Delivery Device, 5-Pack 30U
Omnipod GO Insulin Delivery Device, 5-Pack 15U
Omnipod GO Insulin Delivery Device, 5-Pack 40U
Omnipod GO Insulin Delivery Device, 5-Pack 25U
Omnipod GO Insulin Delivery Device, 5-Pack 20U
Omnipod Dash
Omnipod
SmartBolus Calculator
Omnipod DASH
Omnipod 5 Algorithm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only