FDA Registration
Active
🇺🇸 United States
Giraffe Blue Spot PT Lite
Reg #: 1000122810
·
FEI: 1000122810
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Lumitex Medical Devices, Inc.
- Registration Number
- 1000122810
- FEI Number
- 1000122810
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6611 W Snowville Rd
- City
- Brecksville
- State
- OH
- ZIP
- 44141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120820
Owner / Operator
- Firm Name
- Lumitex Medical Devices, Inc.
- Operator Number
- 9000093
- Address
- 6611 W Snowville Rd, --
- City
- Brecksville
- State
- OH
- Postal Code
- 44141
- Country
- US
- Correspondent
- Kimberly S Tetuan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2013-01-22 |
Proprietary Names
Giraffe Blue Spot PT Lite
Establishment Types
Manufacture Medical Device