Shiley

GUDID 20884521205465

Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula

Covidien LP

Tracheostomy tube, non-reinforced, non-customized, single-use

• Primary Device ID: 20884521205465
• NIH Device Record Key: f67a3661-dff5-40d0-a31a-b5c54d0a71a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shiley
• Version Model Number: 9CN90R
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
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• Length: 79 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 79 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter
• Device Size Text, specify: 0
• Length: 79 Millimeter
• Angle: 90 degree
• Outer Diameter: 12.7 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521205468 [Primary]
GS1	20884521205465 [Package]; Contains: 10884521205468; Package: CASE [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150844

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-07-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Shiley]

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