DEVICE: Portex (00351688038718)

Device Identifier (DI) Information

Portex
597080
In Commercial Distribution

Smiths Medical International Ltd
00351688038718
GS1

1
215591523 *Terms of Use
No description.
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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
Tracheostomy tube cannula, single-use A sterile, hollow, cylindrical, curved device designed as an internal, independent component of a metal or plastic tracheostomy tube. It is made of plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
BTO Tube, tracheostomy (w/wo connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K922749 000
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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
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 Record Status

7e652d10-04ca-41b8-b511-2aaa78f9d53e
July 06, 2018
3
July 29, 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
10351688038715 10 00351688038718 2015-07-31 Not in Commercial Distribution BOX
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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)

[?]
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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No Customer Contact currently defined
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