BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Covidien

    Reg #: 9681384 · FEI: 3002807626 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    147
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    Covidien
    Registration Number
    9681384
    FEI Number
    3002807626
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Avenue Henequen No. 1181, Park Industrial Salvarcar
    City
    Ciudad Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K945406

    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
    Covidien
    Contact Name
    Kae Miller
    Address
    200 Medtronic Dr
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US
    Email
    [email protected]
    Phone
    303 4081427

    Products

    Device Name Product Code
    Tube, Tracheal (W/Wo Connector) BTR
    Laryngoscope, Rigid CCW
    Tube, Tracheostomy (W/Wo Connector) BTO
    Tube, Levine FRQ
    Esophageal Dilator With Balloon And Electrode Sensors PIE
    Tube Tracheostomy And Tube Cuff JOH
    Tube, Feeding FPD
    Ventilator, Non-Continuous (Respirator) BZD
    System, Gastrointestinal Motility (Electrical) FFX
    Device, Warming. Blood And Plasma KZL
    Airway, Nasopharyngeal BTQ
    Stylet, Tracheal Tube BSR
    Esophageal Dilator Balloon With Or Without Electrode Sensors PID
    Mask, Oxygen BYG
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Infusor, Pressure, For I.V. Bags KZD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Continuous Measurement Thermometer FLL
    Ventilator, Continuous, Facility Use CBK
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Catheter, Urological KOD
    Stethoscope, Esophageal, With Electrical Conductors BZT
    Esophagoscope (Flexible Or Rigid) EOX
    Airway, Esophageal (Obturator) CAO

    Proprietary Names

    Uncuffed; Nasal RAE Trach 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 SSV Phonate Shiley Speaking Valve Esoph. Steth w/Temp Sens/Gastric Su Uncuffed Reinforced Trach. Tube EsoFLIP Dilation Catheter 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) Shiley Specialized Trach Tube Feeding Tube Breeze Sleepgear with Dreamseal Flip Topography Module EndoFlip Catheter EndoFlip System Surgery Filter Fluid Warming Cassette Nasopharyngeal Airway Shiley Neonatal/Pediatric Tracheostomy Tube TaperGuard Trach Tubes TaperGuard Evac Trach Tubes STYLET, TRACHEAL TUBE Shiley Disp. Cannula Trach. Tube Hi-Lo Evac & Evac II ET Tubes EndoFLIP Measurement Catheter EsoFLIP ES-330 Single Patient Use Nasal (CPAP) Cir Fluid Warming Cassette Surgery Filter Hi Lo Tracheal Tube with Lanz Shiley 15 MM Cap Neonatal Trach. Tube Shiley Specialized, Pediatric & Pressure Infusor Irrigator Shiley Cuffless Neonatal/Pediatric Tracheostomy Tubes Microstream Luer Adult-Pediatric Intubated Sampling Line Microstream Luer, short-term Microstream Advance Adult-Pediatric, Intubated, 4m, Long term Microstream Advance Intubated, short-term Microstream Advance Adult-Pediatric Intubated FilterLine Microstream Advance Adult-Pediatric Intubated, High-humidity Microstream Advance Adult-Pediatric Intubated, short-term Advance Adult-Pediatric Intubated, 4M, short-term Continuous Measurement Thermometer Shiley Adult Trach. Tubes & Access. RAE II Trach. Tube 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) Shiley Decannulation Plug Hi-Lo Temp Gen. Purpose Temp Probe Falcon Ped Trach. Tubes Shiley Neo Shiley Spare Inner Cannula Shiley Puritan Bennett 980 Series Ventilator System Tracheostomy Tube and Tube Cuff W/ & W/O Tube Gas/Pres Monit ET Conn/Adop Tube, tracheal Foley-Temp Shiley Cuffed Ped. Trach. Tube Hi-Lo Temp Esophageal Steth. Speaking Valve with Oxygen Port SSVO 4070 Temp Monitor Shiley Specialized Tracheostomy Tube EsoFlip Catheter ES-310 Shiley Perc Trach System ES-320 Microstream Advance Pediatric Oral- Nasal, with O2 tubing, short-term Microstream Advance Adult Bite Block, short-term Microstream Advance Pediatric Oral- Nasal, short-term Microstream Advance Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 tubing, 4m, short-term MIcrostream Luer Adult Nasal, with O2 tubing, short-term Microstream Advance Pediatric Nasal, short-term Microstream Advance Adult Nasal, short-term MIcrostream Luer Pediatric Oral-Nasal, with O2, short-term Microstream Luer Adult Oral-Nasal Sampling Line Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, extended duration Microstream Advance Pediatric Oral-Nasal FilterLine with O2 Tubing MIcrostream Luer Pediatric Nasal, with O2 tubing, short-term Microstream Advance Adult Oral-Nasal, with O2 connector, 4m, short-term Microstream Advance Adult Oral-Nasal FilterLine with O2 tubing Microstream Advance Neonatal-Infant Nasal FilterLIne with O2 Tubing MIcrostream Luer Adult Oral-Nasal, with O2 tubing, short-term Microstream Advance Pediatric Oral-Nasal, 4m, with O2 tubing, short-term Microstream Advance Adult Oral Nasal CO2 Filter Line with O2 Tubing, 4M, extended duration Microstream Advance Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, with O2 connector Microstream Luer Adult Bite Block, with O2 tubing, 4M, short-term Microstream Advance Adult Oral-Nasal, 4m, with O2 tubing, short-term Microstream Luer Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Bite Block, with O2 tubing, short-term Microstream Advance Adult Nasal, with O2 Tubing, short term Microstream Advance Adult Oral-Nasal, with O2 tubing, short-term Cytosponge incuTemp Sensors/Adhesive Covers MON-A-THERM'S SKIN TEMPERATURE SENSOR Esophageal Tracheal Airway SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS SHILEY PEDIATRIC TRACHEOS Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM Mon-a-Therm™ General Purpose Temperature Probe 400TM

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)