DEVICE: Provox® ActiValve® (07331791000645)
Device Identifier (DI) Information
Provox® ActiValve®
XtraStrong
In Commercial Distribution
7167
Atos Medical AB
XtraStrong
In Commercial Distribution
7167
Atos Medical AB
The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability and providing an even sealing surface for the valve flap. The blue ring and valve flap can be seen on X-ray. Magnets in the ring and valve flap determine the force needed to open the valve (the magnets are not adjustable). Provox ActiValve comes in different opening forces.
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
62094 | Tracheoesophageal speech valve, indwelling, non-sterile |
A non-sterile device designed to be inserted into a surgically-created tracheoesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced as needed by a medical professional. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). It is routinely cleaned by the user in situ and assistive cleaning devices (e.g., brush) may be included. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWL | Prosthesis, Laryngeal (Taub) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092593 | 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 |
---|
Length: 8 Millimeter |
Device Record Status
4989c1f2-ab0d-45c7-90e7-c8a237f07879
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