DEVICE: TRACOE® comfort (04035324026227)
Device Identifier (DI) Information
TRACOE® comfort
REF 888-204-13A-O
In Commercial Distribution
Tracoe medical GmbH
REF 888-204-13A-O
In Commercial Distribution
Tracoe medical GmbH
Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port
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? |
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35404 | Tracheostomy tube, non-reinforced, non-customized, single-use |
A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BTO | Tube, tracheostomy (w/wo connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K781729 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Products must be stored in cool and dry location. Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 11.8 Millimeter |
Device Record Status
9c595a3a-8500-48e0-ba3d-5edf8a1176cb
June 05, 2020
4
July 03, 2017
June 05, 2020
4
July 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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
[?]
+49613691690
info@tracoe.com
info@tracoe.com