Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013242701

FEI Number

3013242701

Entity Name

MEDTRONIC ITALIA

City/State/Country

Rolo Reggio Emilia, IT

Establishment Address

Via Campogrande 43, Rolo Reggio Emilia 42047, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Barrierbac Barrierbac S Hygroster Flexlife Spirobac (& Adapters) Airway Connector with Flex Tube Hygrolife HME for Tracheostomized Patients

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2008-02-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2008-02-15
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-02-14
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2008-02-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2008-02-15
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	1993-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: Medtronic formerly Covidien Email: kae.miller@medtronic.com Phone: (303) 4081427

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Similar Registrations

Registration Number	Establishment Name	Location
3007337939	FLODINS FILTER AB	Lysekil Vastra Gotaland, SE
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3007289408	Medline Canada	Guelph Ontario, CA
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013242701. Last updated year: 2026. Please use registration number 3013242701 when referencing this establishment in official correspondence.