FDA Registration
Active
🇺🇸 United States
iLet Insulin Infusion Kit - Contact Detach
Reg #: 3019004087
·
FEI: 3019004087
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BETA BIONICS, INC.
- Registration Number
- 3019004087
- FEI Number
- 3019004087
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11 Hughes
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041545
Owner / Operator
- Firm Name
- Beta Bionics, Inc.
- Operator Number
- 10088071
- Address
- 11 Hughes
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Neal Grant
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-05-23 |
Proprietary Names
iLet Insulin Infusion Kit - Contact Detach
Establishment Types
Repack or Relabel Medical Device