FDA Registration
Active
🇺🇸 United States
DRE Infantia NB 500 Incubator
Reg #: 1000122786
·
FEI: 1000122786
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRE Med
- Registration Number
- 1000122786
- FEI Number
- 1000122786
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2601 Stanley Gault PKWY
- City
- Louisville
- State
- KY
- ZIP
- 40223
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132543
Owner / Operator
- Firm Name
- DRE Resume LLC
- Operator Number
- 10092249
- Address
- 2601 Stanley Gault Pkwy, STE 101
- City
- Louisville
- State
- KY
- Postal Code
- 40223
- Country
- US
- Correspondent
- Carlos Borges
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2024-12-17 |
Proprietary Names
DRE Infantia NB 500 Incubator
Establishment Types
Repack or Relabel Medical Device