Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020893

FEI Number

3002807850

Entity Name

Covidien

City/State/Country

- Galway, IE

Establishment Address

Michael Collins Road, H91 W9N4 Mervue, - Galway -, IE

Establishment Type(s)

Manufacture Medical 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

K091224

PMA Number

N/A

All Registered Proprietary Names

Renaissance 11 Spirometry System Puritan Bennett 840 Series Ventilator System INVOS rSO2 Micro-module (PMC71VP-GE) INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor Oximeter Oximax Pulse Oximetry System e360 HT70 N65 Puritan Bennett 980 Series Ventilator System DC compressor Invos Cerebral/Somatic Oximeter Sys: 5100C Endoflip 300 System Nellcor Bedside Respiratory Patient Monitoring System OxyAlert NIR Sensors, Access for Invos 5100C Sys: IS-C, IS-S, IS Oxyalert Nirsensors, Access for Invos 5100C Sys: IS-C, IS-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2008-02-26
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-04-11
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2022-01-31
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-01-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-05-21
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2008-02-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-02-26
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2014-07-31
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-02-26
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2015-02-26
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-02-26
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2016-03-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-12-02
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2015-01-07
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2010-11-11
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2023-07-28
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2015-03-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-03-06
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2010-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: Medtronic formerly Covidien Email: kae.miller@medtronic.com Phone: (303) 4008142

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
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19
K142547	Covidien	Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm	2014-12-09
K130320	Covidien	BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW	2014-02-04
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020893. Last updated year: 2026. Please use registration number 8020893 when referencing this establishment in official correspondence.