Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681384

FEI Number

3002807626

Entity Name

Covidien

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

Avenue Henequen No. 1181, Park Industrial Salvarcar, Ciudad Juarez Chihuahua 32573, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K852632

PMA Number

N/A

All Registered 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 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 EsoFLIP Dilation Catheter Puritan Bennett 980 Series Ventilator System Tracheostomy Tube and Tube Cuff W/ & W/O Tube Gas/Pres Monit ET Conn/Adop

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-27
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2005-10-24
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-02-15
FRQ	Tube, Levine	Gastroenterology, Urology	Class 2	876.5980	2008-02-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-27
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2020-03-11
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2020-03-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-05-22
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2010-03-29
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2008-02-27
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-26
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-08-20
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2008-03-28
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2007-04-25
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2019-04-01
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2009-04-06
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-02-27
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-02-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-02-01
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2020-03-11
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2014-01-06
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2014-01-06
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2008-02-26
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2009-03-12
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2009-04-24
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2008-02-27
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2010-03-29
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2003-07-01
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2018-09-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-11-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-12-04
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
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2023-08-31
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-11-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-02-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2015-12-16
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	2008-11-11
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2015-07-14
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2020-03-11
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2020-03-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-12-02
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2015-02-25
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2008-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Business: Covidien Email: kae.miller@medtronic.com Phone: (303) 4081427

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
2024500	COVIDIEN	CARLSBAD, CA, US

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-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-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681384. Last updated year: 2026. Please use registration number 9681384 when referencing this establishment in official correspondence.