FDA Registration
Active
🇺🇸 United States
TransMedics Lung Perfusion Set, including the TransMedics Lung Perfusion Module
Reg #: 3003152463
·
FEI: 3003152463
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TRANSMEDICS, INC.
- Registration Number
- 3003152463
- FEI Number
- 3003152463
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 200 MINUTEMAN RD STE 302
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
Owner / Operator
- Firm Name
- TransMedics
- Operator Number
- 10045349
- Address
- 200 Minuteman Road, Suite 302
- City
- Andover
- State
- MA
- Postal Code
- 01810
- Country
- US
- Correspondent
- Miriam Provost
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | Class 2 | Gastroenterology, Urology | No | 2013-11-07 |
Proprietary Names
TransMedics Lung Perfusion Set, including the TransMedics Lung Perfusion Module
TransMedics Organ Care System
TransMedics Heart Solution Set
TransMedics Heart Perfusion Set, including the TransMedics Heart Perfusion Module
TransMedics Organ Care System Lung Console
TransMedics Lung Solution Set
TransMedics Organ Care System Heart Console
Establishment Types
Manufacture Device in the United States for Export Only