FDA Registration
Active
🇺🇸 United States
COVIDIEN
Reg #: 2024500
·
FEI: 2024500
·
Expires 2026
Products
16
Proprietary Names
25
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- COVIDIEN
- Registration Number
- 2024500
- FEI Number
- 2024500
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2101 Faraday Avenue
- City
- CARLSBAD
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021573
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2008-02-26 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2008-02-26 |
| NSX | No | 2011-04-14 | |||
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2015-01-07 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2008-02-26 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2015-04-28 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2015-02-26 |
| Airway Monitoring System | OQU | Class 2 | Anesthesiology | No | 2025-03-14 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 1991-12-23 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2016-03-09 |
| Accessory To Continuous Ventilator (Respirator) | MOD | Class 2 | Anesthesiology | No | 2015-04-28 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2008-02-28 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2015-04-28 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2008-02-28 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2015-04-28 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2009-11-18 |
Proprietary Names
840 Vent with VV+
Renaissance 11 Spirometry System
Clinivision
DC compressor
Ventilator
Puritan Bennett 840 Series Ventilator System
Breeze Sleepgear with Dreamseal
Spirometer
Compressor
HT70
SonarMed AirWave Airway Monitoring System
Puritan Bennett 980 Series Ventilator System
U-MID VENTILATOR CIRCUITS
PMR-2 Puritan Manual Resuscitator
Nebulizer
Humidifier-Cascade II
Humidifier
Pyramesh
INDGO Manual Resuscitator
Resuscitator
DMR Plus Disposable Manual
Capno-Flo
Mixer
MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
e360
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198