BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Covidien

    Reg #: 2936999 · FEI: 2936999 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    182
    Establishment Types
    3
    Classifications
    41

    Registration Details

    Registration Name
    Covidien
    Registration Number
    2936999
    FEI Number
    2936999
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 Medtronic Dr
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141542

    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
    Oximeter DQA
    Tube Tracheostomy And Tube Cuff JOH
    Catheter, Urological KOD
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Airway, Nasopharyngeal BTQ
    Stethoscope, Esophageal, With Electrical Conductors BZT
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Tube, Tracheal (W/Wo Connector) BTR
    Tube, Feeding FPD
    Mask, Oxygen BYG
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Oximeter, Tissue Saturation MUD
    Filter, Bacterial, Breathing-Circuit CAH
    Monitor, Breathing Frequency BZQ
    Cerebral Oximeter QEM
    Laryngoscope, Rigid CCW
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Connector, Airway (Extension) BZA
    System, Thermal Regulating DWJ
    Tape And Bandage, Adhesive KGX
    Oximeter, Ear DPZ
    Mask, Gas, Anesthetic BSJ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Cuff, Tracheal Tube, Inflatable BSK
    Electrode, Cutaneous GXY
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Tube, Bronchial (W/Wo Connector) BTS
    Medical Device Data System OUG
    Stylet, Tracheal Tube BSR
    Display, Cathode-Ray Tube, Medical DXJ
    Transducer, Blood-Pressure, Extravascular DRS
    Catheters, Suction, Tracheobronchial BSY
    Oximeter, Reprocessed NLF
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Tube, Levine FRQ
    Infusor, Pressure, For I.V. Bags KZD
    Injector And Syringe, Angiographic DXT
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Airway, Oropharyngeal, Anesthesiology CAE

    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 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 Puritan Bennett Cuff Pressure Manager Pediatric Sensor TaperGuard Trach Tubes TaperGuard Evac Trach Tubes U-MID VENTILATOR CIRCUITS BronchoCath Shiley™ 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 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 INVOS™ rSO2 Micro-module (PMC71VP-GE) INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor Shiley Adult Flexible EVAC Tracheostomy Tube with TaperGuard Cuff Warmtouch Blanket Esoph. Steth w/Temp Sens/Gastric Su Pressure Infusor Irrigator Shiley Decannulation Plug Shiley Specialized Trach Tube breathing circuit Male to male adapter Y PIECE) High Pressure Flex ConnectingTubing Quatro Covidien Nellcor Adult Respiratory Sensor Covidien Nellcor Respiration Rate Software, Version 1 Nellcor™ USB Pulse Oximetry Monitor Interface Cable Guedel Airway 4070 Temp Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198