Shiley

GUDID 90884521554548

Pediatric Specialized Tracheostomy Tube

Covidien LP

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID90884521554548
NIH Device Record Key79e82323-33e9-459d-b2a7-5287bdfeb2d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameShiley
Version Model NumberM2.5PT
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

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Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521554542 [Primary]
GS190884521554548 [Package]
Contains: 10884521554542
Package: CS [99 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOHTube tracheostomy and tube cuff

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-07-18
Device Publish Date2015-10-23

On-Brand Devices [Shiley]

70884522007575TaperGuard Oral/Nasal Tracheal Tube,Murphy Eye
80884522011593CPAP System For Dual Lumen Tracheal Tube
50884522029207Tracheal Tube Cuffless Reinforced
40884522029194Tracheal Tube Cuffless Reinforced
40884522029187Tracheal Tube Cuffless Reinforced
50884522029177Tracheal Tube Cuffless Reinforced
50884522029160Tracheal Tube Cuffless Reinforced
40884522029156Tracheal Tube Cuffless Reinforced
40884522029149Tracheal Tube Cuffless Reinforced
50884522007533TaperGuard Oral/Nasal Tracheal Tube,Murphy Eye
30884522007140Tracheostomy Tube Cuffed with Inner Cannula
50884522007137Tracheostomy Tube Cuffed with Inner Cannula
50884522007120Tracheostomy Tube Cuffed with Inner Cannula
50884522007113Tracheostomy Tube Cuffed with Inner Cannula
50884522007038Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated
50884522007021Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated
50884522006987Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated
50884522006970Tracheostomy Tube Cuffless with Inner Cannula
50884522006963Tracheostomy Tube Cuffless with Inner Cannula
50884522006956Tracheostomy Tube Cuffless with Inner Cannula
40884522006942Tracheostomy Tube Cuffless with Inner Cannula
50884522006734Inner Cannula XLT,Disposable
50884522006727Inner Cannula XLT,Disposable
40884522006713Inner Cannula XLT,Disposable
30884522006501Nasal RAE Tracheal Tube Cuffless,Murphy Eye
70884522005359Cap
50884522005331Inner Cannula,Fenestrated, Disposable
40884522005327Inner Cannula,Disposable
40884522005297Inner Cannula,Fenestrated, Disposable
50884522005287Inner Cannula,Disposable
40884522005259Inner Cannula,Fenestrated, Disposable
50884522005249Inner Cannula,Disposable
50884522005218Inner Cannula,Fenestrated, Disposable
50884522005201Inner Cannula,Disposable
10884522004053Oral RAE Tracheal Tube Cuffed,Murphy Eye
20884522000786Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye
30884522000165Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Murphy Eye
40884521133137Nasopharyngeal Airway
40884521133120Nasopharyngeal Airway
50884521133110Nasopharyngeal Airway
50884521133103Nasopharyngeal Airway
40884521133083Nasopharyngeal Airway
40884521133076Nasopharyngeal Airway
60884522007721Speaking Valve
60884522007103Laryngectomy Tube
60884522007097Laryngectomy Tube
60884522007080Laryngectomy Tube
40884522007017Tracheostomy Tube Cuffed with Inner Cannula,Fenestrated
60884522006939Tracheostomy Tube Cuffless with Inner Cannula,Fenestrated
60884522006915Tracheostomy Tube Cuffless with Inner Cannula,Fenestrated

Trademark Results [Shiley]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SHILEY
SHILEY
87453058 5667132 Live/Registered
Covidien LP
2017-05-17
SHILEY
SHILEY
73109823 1107132 Live/Registered
SHILEY LABORATORIES, INC.
1976-12-16

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