DEVICE: LMA (05060112313295)

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Device Identifier (DI) Information

LMA
IPN046010
EID200
TELEFLEX INCORPORATED
05060112313295
GS1
1
Esophageal Intubation Detector - Bulb
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Suction oesophageal intubation detector, adult A device designed to verify endotracheal (ET) tube placement by the application of a partial vacuum (using a plunger syringe or a self-inflating bulb) through a small calibre tube introduced into the tracheal tube during airway management. It is used during adult intubation. This device exploits the anatomic difference between the trachea and the oesophagus: when the detector bulb or syringe is depressed (a partial vacuum is applied) it refills with air if the intubation is tracheal, and fails to fill if the intubation is oesophageal (the oesophagus collapses around the tube). It is used in healthcare facilities or in the field to evaluate oesophageal intubation. 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

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 16, 2016

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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
25060112313299 20 05060112313295 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
Yes
No CLOSE

Customer Contact

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