FDA Registration
Active
🇮🇪 Ireland
Covidien
Reg #: 8020893
·
FEI: 3002807850
·
Expires 2026
Products
14
Proprietary Names
42
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- Covidien
- Registration Number
- 8020893
- FEI Number
- 3002807850
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Michael Collins Road, H91 W9N4 Mervue
- City
- - Galway
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K022103
- PMA Number
- P020045
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 4008142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2008-02-26 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2016-04-11 |
| Cerebral Oximeter | QEM | Class 2 | Cardiovascular | No | 2022-01-31 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2022-01-31 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-05-21 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2008-02-26 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2015-02-26 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2016-03-09 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2015-01-07 |
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2023-07-28 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2015-03-06 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2005-10-24 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2024-02-07 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2015-04-28 |
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
Flip Topography Module
EndoFlip Catheter
EndoFlip System
McGRATH MAC+ connected video laryngoscope (302-000-000)
McGRATH MAC+ connected video laryngoscope
MCGRATH MAC EMS Video Laryngoscope
MCGRATH MAC Video Laryngoscope
McGRATH MAC, MAC 4 Disposable Laryngoscope Blade
McGRATH MAC 2 Disposable Laryngoscope Blades (carton of 50)
McGRATH X Blade, X3 Disposable Laryngoscope Blade
McGRATH MAC 3.6V Battery
McGRATH X Blade, X2 Disposable Laryngoscope Blade (carton of 10)
McGRATH MAC, MAC 4 Disposable Laryngoscope Blade (carton of 50)
McGRATH MAC 1 Disposable Laryngoscope Blade
McGRATH MAC, MAC 3 Disposable Laryngoscope Blade (carton of 50)
McGRATH MAC 1 Disposable Laryngoscope Blades (carton of 50)
McGRATH X Blade, X3 Disposable Laryngoscope Blade (carton of 10)
McGRATH X Blade, X2 Disposable Laryngoscope Blade
McGrath MAC EMS 3.6V Battery
McGRATH MAC, MAC 2 Disposable Laryngoscope Blade
McGRATH MAC, MAC 3 Disposable Laryngoscope Blade
McGRATH Rechargeable Battery
840 Vent with VV+
LAMP-C
Nitron CryoConsole
Mixer
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility