DEVICE: Provox® Plug (07331791000782)
Device Identifier (DI) Information
Provox® Plug
7205
In Commercial Distribution
Atos Medical AB
7205
In Commercial Distribution
Atos Medical AB
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.
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWL | Prosthesis, Laryngeal (Taub) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K940638 | 000 |
Sterilization
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. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
84e4afec-75b8-498a-8d1b-ef9b0a81cf56
July 06, 2018
3
September 11, 2016
July 06, 2018
3
September 11, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+4641519800
info@atosmedical.com
info@atosmedical.com