FDA Registration
Active
🇺🇸 United States
Omnipod GO Insulin Delivery Device, 5-Pack 30U
Reg #: 3014585508
·
FEI: 3014585508
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Insulet Corporation
- Registration Number
- 3014585508
- FEI Number
- 3014585508
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 Nagog Park
- City
- Acton
- State
- MA
- ZIP
- 01720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223372
Owner / Operator
- Firm Name
- INSULET CORPORATION
- Operator Number
- 9056196
- Address
- 100 Nagog Park, --
- City
- Acton
- State
- MA
- Postal Code
- 01720
- Country
- US
- Correspondent
- Laetitia Cousin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2023-05-16 |
Proprietary Names
Omnipod GO Insulin Delivery Device, 5-Pack 30U
Omnipod GO Insulin Delivery Device, 5-Pack 20U
Omnipod GO Insulin Delivery Device, 5-Pack 25U
Omnipod GO Insulin Delivery Device, 5-Pack 10U
Omnipod GO Insulin Delivery Device, 5-Pack 15U
Omnipod GO Insulin Delivery Device, 5-Pack 40U
Omnipod GO Insulin Delivery Device, 5-Pack 35U
Establishment Types
Manufacture Medical Device