FDA Registration
Active
🇮🇹 Italy
MEDTRONIC ITALIA
Reg #: 3013242701
·
FEI: 3013242701
·
Expires 2026
Products
3
Proprietary Names
15
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MEDTRONIC ITALIA
- Registration Number
- 3013242701
- FEI Number
- 3013242701
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Campogrande 43
- City
- Rolo Reggio Emilia
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K941536
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
US Agent
- Business Name
- Medtronic formerly Covidien
- Contact Name
- Kae Miller
- Address
- 200 Medtronic Drive
- City
- Lafayette
- State
- CO
- ZIP
- 80026
- Country
- US
- [email protected]
- Phone
- 303 4081427
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2008-02-15 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2008-02-15 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2008-02-15 |
Proprietary Names
Barrierbac
Barrierbac S
Hygroster
Flexlife
Spirobac (& Adapters)
Airway Connector with Flex Tube
Hygrolife
HME for Tracheostomized Patients
Tracheolife
Sterivent
Sterivent S
Hygrobac
Hybrobac S
Hygrobaby
Hygroboy
Establishment Types
Export Device to the United States But Perform No Other Operation on Device