Covidien

FDA Device Registration & Listing · Lafayette, CO, US · Registration 2936999

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2936999
FEI Number
2936999
Entity Name
Covidien
City/State/Country
Lafayette, CO, US
Establishment Address
200 Medtronic Dr, Lafayette, CO 80026, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Covidien llc (Owner Number: 1282497)
Owner / Operator Contact Address
15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nellcor Portable SpO2 Patient Monitoring System Shiley Extended XLT Foley-Temp HME for Tracheostomized Patients Nasopharyngeal Airway Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM Hi-Lo Temp Gen. Purpose Temp Probe Pedi-Cap Shiley Adult Trach. Tubes & Access. Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115- XXOR) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119- XXNR) Feeding Tube Single Patient Use Nasal (CPAP) Cir Neonatal Trach. Tube Shiley Specialized, Pediatric & OxyAlert NIR Sensors, Access for Invos 5100C Sys: IS-C, IS-S, IS Oxyalert Nirsensors, Access for Invos 5100C Sys: IS-C, IS-S ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 87460 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (6 mm) 87465 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (6.5 mm) 87435 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3.5 mm) 87475 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (7.5 mm) 87450 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (5 mm) 87455 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (5.5 mm) Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP 87470 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (7 mm) 87480 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (8 mm) 87440 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (4 mm) 87445 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (4.5 mm) 87485 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (8.5 mm) 87490 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (9 mm) 87430 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3 mm ) 87495 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (9.5 mm) 87410 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (10mm) Hi-Lo Temp Esophageal Steth. LAMP-C SealGuard Evac Tracheal Tubes SealGuard Tracheal Tubes Tube, tracheal INVOS™ PM7100 Patient Monitor Uncuffed; Nasal RAE Trach Falcon Nellcor N-200 Pulse Oximeter 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 Shiley Cuffed Ped. Trach. Tube Vital Sync W/ & W/O Tube Gas/Pres Monit ET Conn/Adop Nellcor Bedside SP02 Patient Monitoring System GE ApexPro FH SpO2 - Nellcor Cable GE ApexPro CH SpO2 - Nellcor Cable Hygrobac Hybrobac S Hygrobaby Hygroboy Reflectance Sensor Nellcor Bedside Respiratory Patient Monitoring System Airway Connector with Flex Tube Warmtouch Cardiac Blanket Shiley Oximax Softcare Sensors Oximeter Mon-a-Therm™ General Purpose Temperature Probe 400TM Ped Trach. Tubes Shiley Neo SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOS Oximeter Pediatric-Infant Adhesive Sensor Wrap Adult-Neonatal Adhesive Sensor Wrap Adult-Neonatal Foam Sensor Wrap Pediatric-Infant Foam Sensor Wrap Oximax Pulse Oximetry System 86150 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5 mm) Shiley Pediatric Oral/Nasal ETT with TaperGuard Cuff 86125 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (2.5 mm) 86145 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4.5 mm) 86140 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (4 mm) 86135 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3.5 mm) 86155 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (5.5 mm) 86130 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (3 mm) 86160 Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (6 mm) LaserFlex Shiley 15 MM Cap RAE II Trach. Tube Anesthesia Face Mask SSV Phonate Shiley Speaking Valve Tracheolife Vital Sync Puritan Bennett Cuff Pressure Manager Pediatric Sensor TaperGuard Trach Tubes TaperGuard Evac Trach Tubes U-MID VENTILATOR CIRCUITS BronchoCath Shiley™ Vital Sync LaserFlex Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector, Nellcor™ PEDICAP Pediatric Colorimetric CO2 Detector Speaking Valve with Oxygen Port SSVO Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Hygrolife Barrierbac Barrierbac S Shiley Disp. Cannula Trach. Tube Hygroster WarmTouch STYLET, TRACHEAL TUBE Vityl Sync Informatics Manager & Virtual Patient Monitoring Platform N-560 PULSE OXIMETER Disp. Dome WarmTouch Blanket Sterivent Sterivent S Ty-Care/Ty-Care Exel Closed S Shiley Neonatal/Pediatric Tracheostomy Tube & Oximax Sensors Reprocessed Nellcor Oxisensor II Tracheostomy Tube and Tube Cuff incuTemp Sensors/Adhesive Covers MON-A-THERM'S SKIN TEMPERATURE SENSOR Shiley™ Adult Flexible Disposable Inner Cannula XLT Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula Uncuffed Reinforced Trach. Tube Safety Flex Spirobac (& Adapters) BronchoCath with CPAP Shiley™ Hi-Lo Evac & Evac II ET Tubes Shiley Perc Trach System Oxisensor II N-395 Oximeter Flexlife Shiley Spare Inner Cannula Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor Invos Cerebral/Somatic Oximeter Sys: 5100C CPAP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2014-10-16
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-02-01
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2008-02-27
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 1993-01-06
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2007-04-25
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2026-04-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-02-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2008-02-28
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-02-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2026-04-17
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2008-02-27
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2008-02-26
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2010-03-29
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2010-11-11
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2009-04-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2024-05-22
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2008-02-27
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2014-02-20
DQA Oximeter Cardiovascular Class 2 870.2700 2014-02-20
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-10-28
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-01
QEM Cerebral Oximeter Cardiovascular Class 2 870.2700 2019-01-09
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2019-01-09
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2015-12-16
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-28
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2005-10-24
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-02-27
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2014-04-11
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2008-02-27
DQA Oximeter Cardiovascular Class 2 870.2700 2012-07-25
DQA Oximeter Cardiovascular Class 2 870.2700 2020-08-10
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2008-02-15
DQA Oximeter Cardiovascular Class 2 870.2700 2008-03-07
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2015-03-06
DQA Oximeter Cardiovascular Class 2 870.2700 2015-03-06
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2008-02-15
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2008-02-26
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2015-07-14
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-28
DQA Oximeter Cardiovascular Class 2 870.2700 2015-03-31
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-04-20
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-02-27
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2012-10-15
DQA Oximeter Cardiovascular Class 2 870.2700 2013-05-21
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2000-05-02
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2008-02-26
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-26
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2023-08-31
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-01-30
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-02-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-27
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2009-11-18
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2008-02-15
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2008-02-15
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2013-05-21
BSK Cuff, Tracheal Tube, Inflatable Anesthesiology Class 2 868.5750 2021-01-15
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-07
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2009-04-06
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 1991-12-23
BTS Tube, Bronchial (W/Wo Connector) Anesthesiology Class 2 868.5720 2008-02-01
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2013-12-12
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-12-12
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-01
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-27
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2010-01-29
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2026-04-20
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 2008-02-15
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2008-02-27
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2008-02-15
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2015-06-02
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2008-02-27
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-06-29
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2017-06-29
DXJ Display, Cathode-Ray Tube, Medical Cardiovascular Class 2 870.2450 2017-06-29
DQA Oximeter Cardiovascular Class 2 870.2700 1993-12-10
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2008-10-30
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2013-07-30
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2008-02-15
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2008-02-15
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2019-04-01
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2008-03-28
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2015-02-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-02-27
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2026-03-03
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-01
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2008-02-14
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2008-02-01
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2008-02-01
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2008-02-27
DQA Oximeter Cardiovascular Class 2 870.2700 2008-10-30
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2008-02-15
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2008-11-11
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-22
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2010-11-11
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2002-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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-0112-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
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-0180-2015 Nellcor Puritan Bennett Inc. (dba Covidien LP) 2
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2936999. Last updated year: 2026. Please use registration number 2936999 when referencing this establishment in official correspondence.
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