DEVICE: LMA (05060112313295)
Device Identifier (DI) Information
LMA
IPN046010
In Commercial Distribution
EID200
TELEFLEX INCORPORATED
IPN046010
In Commercial Distribution
EID200
TELEFLEX INCORPORATED
Esophageal Intubation Detector - Bulb
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
36290 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTR | Tube, tracheal (w/wo connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K990556 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9fba79a6-5014-4fc4-92b2-b5d0ffcd6733
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
25060112313299 | 20 | 05060112313295 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM