DEVICE: Portex (00351688018246)

Device Identifier (DI) Information

Portex
519000
In Commercial Distribution

Smiths Medical International Ltd
00351688018246
GS1

1
215591523 *Terms of Use
No description.
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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
Tracheostomy tube decannulation cap A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

9c96f852-1e86-4857-aa3b-5732bb48104c
March 29, 2018
2
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
10351688018243 10 00351688018246 In Commercial Distribution CARTON
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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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