FDA Registration
Active
🇲🇽 Mexico
Livongo Health Inc.
Reg #: 3013160357
·
FEI: 3013160357
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- RR Donnelley Global Turnkey Solutions
- Registration Number
- 3013160357
- FEI Number
- 3013160357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Blvd Internacional 881, San Jeronimo, CD
- City
- Juarez Chihuahua
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K133584
Owner / Operator
- Firm Name
- RR Donnelley Global Turnkey Solutions
- Operator Number
- 10052247
- Address
- 6315 W BY NORTHWEST BLVD
- City
- Houston
- State
- TX
- Postal Code
- 77040
- Country
- US
- Correspondent
- Lee Rush
US Agent
- Business Name
- RR Donnelley
- Contact Name
- Lee Rush
- Address
- 6315 North by Northwest Blvd., Houston
- City
- Houston
- State
- TX
- ZIP
- 77040
- Country
- US
- [email protected]
- Phone
- 979 4841734
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2020-09-07 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2020-09-07 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2020-09-07 |
Proprietary Names
Livongo Health Inc.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)