FDA Registration
Active
🇺🇸 United States
iLet Insulin Infusion Kit Contact Detach (23", 6mm)
Reg #: 3019004087
·
FEI: 3019004087
·
Expires 2025
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
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
- K021475
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 |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-05-23 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-05-23 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-05-23 |
Proprietary Names
iLet Insulin Infusion Kit Contact Detach (23", 6mm)
iLet Cartridge Kit
iLet Insulin Infusion Kit Inset (23", 6mm)
iLet Insulin Infusion Kit Inset (32", 6mm)
Establishment Types
Repack or Relabel Medical Device