FDA Registration
Active
🇺🇸 United States
Dexcom G6 Pro Continuous Glucose Monitoring System
Reg #: 2024024
·
FEI: 2024024
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Sterigenics Radiation Technologies, LLC
- Registration Number
- 2024024
- FEI Number
- 2024024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7695 Formula Pl
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221259
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | Class 2 | Clinical Chemistry | No | 2024-10-22 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2024-10-22 |
| Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | QDK | Class 2 | Clinical Chemistry | No | 2024-10-22 |
Proprietary Names
Dexcom G6 Pro Continuous Glucose Monitoring System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)