DEVICE: Provox® Plug (07331791000782)

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Device Identifier (DI) Information

Provox® Plug
7205

Atos Medical AB
07331791000782
GS1
1
The Provox Plug is a first-aid tool for temporarily stopping leakage through the voice prosthesis. The device is inserted into the opening of the Provox voice prosthesis. The medallion end can be taped to the skin if desired.
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Device Characteristics

MR Unsafe
No
No
Yes
No
Yes
Yes
Yes
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Tracheoesophageal speech valve occluder, non-valved A non-sterile device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 11, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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
Yes
No CLOSE

Customer Contact

[?]
+4641519800
info@atosmedical.com
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