DEVICE: TELEFLEX (04026704588367)

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Device Identifier (DI) Information

TELEFLEX
IPN044813
5-13016
TELEFLEX INCORPORATED
04026704588367
GS1
1
TFX ISIS SUBGLOTTIC SEC. ETT, 8.0
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cuff-suction endotracheal tube A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
BTR Tube, tracheal (w/wo connector)
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
Length: 15 Millimeter
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Device Status

In Commercial Distribution
October 16, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
24026704588361 10 04026704588367 In Commercial Distribution Box
44026704588365 10 24026704588361 In Commercial Distribution Case
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(919)544-8000
CS@TELEFLEX.COM
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