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
Phone
303 4081427

Products

Device Name Product Code
Filter, Bacterial, Breathing-Circuit CAH
Condenser, Heat And Moisture (Artificial Nose) BYD
Connector, Airway (Extension) BZA

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