FDA Registration
Active
🇺🇸 United States
8004032
Reg #: 1832562
·
FEI: 1832562
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Pulmodyne Inc.
- Registration Number
- 1832562
- FEI Number
- 1832562
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2055 Executive Dr
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
Owner / Operator
- Firm Name
- ENGINEERED MEDICAL SYSTEMS
- Operator Number
- 9022693
- Address
- 2055 EXECUTIVE DR., --
- City
- INDIANAPOLIS
- State
- IN
- Postal Code
- 46241
- Country
- US
- Correspondent
- TAMARA - LEFEVERS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2025-04-10 |
Proprietary Names
8004032
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)