DEVICE: Mallinckrodt (10884521171985)

Device Identifier (DI) Information

Mallinckrodt
96585
Not in Commercial Distribution
96585
Covidien LP
10884521171985
GS1
March 11, 2019
1
058614483 *Terms of Use
Oral/Nasal Tracheal Tube with TaperGuard Cuff;Reinforced, Murphy Eye
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46967 Basic endotracheal tube, single-use
A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BTR Tube, tracheal (w/wo connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K871204 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Outer Diameter,11.6,MM;Cuff Resting Diameter,28.6,MM;Inner Diameter,8.5,MM;
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Device Record Status

af86c91b-7782-4689-81cb-16753394d6af
June 24, 2025
7
October 22, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20884521171982 5 10884521171985 2019-03-11 Not in Commercial Distribution CASE
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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