DEVICE: TRACOE® modular (04035324054510)

Device Identifier (DI) Information

TRACOE® modular
REF 650-S
In Commercial Distribution

Tracoe medical GmbH
04035324054510
GS1

1
319414785 *Terms of Use
TRACOE phon assist I
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Tracheostomy tube speech valve A device that is attached to a tracheostomy tube and is designed to eliminate the necessity of finger occlusion, enabling the tracheostomized patient to speak easily and more clearly. It can be made of metal [e.g., silver (Ag)] or plastic. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
JOH Tube tracheostomy and tube cuff
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
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.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Fits to 22 mm adapter
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Device Record Status

387de581-9679-4677-b5a9-43ff41ab7591
March 29, 2018
2
October 18, 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
No Package DIs found
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49613691690
info@tracoe.com
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