FDA Registration
Active
🇺🇸 United States
Rosie Connectivity Solutions, Inc.
Reg #: 3005393828
·
FEI: 3005393828
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- Rosie Connectivity Solutions, Inc.
- Registration Number
- 3005393828
- FEI Number
- 3005393828
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7320 Central Ave
- City
- SAVANNAH
- State
- GA
- ZIP
- 31406
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100322
Owner / Operator
- Firm Name
- Rosie Connectivity Solutions, Inc.
- Operator Number
- 10062214
- Address
- 7320 Central Ave
- City
- Savannah
- State
- GA
- Postal Code
- 31406
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2026-02-26 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2026-02-26 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2026-02-26 |
Proprietary Names
Rosie RealTime Glucose Control Solution Set
Rosie RealTime Blood Glucose Teset Strips (50/box)
Rosie RealTime Blood Glucose Monitoring System
Rosie RealTime Blood Glucose Test_Strips Foil Wrap
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility