DEVICE: Provox® FreeHands HME® (07331791002885)
Device Identifier (DI) Information
Provox® FreeHands HME®
7710
Not in Commercial Distribution
Atos Medical AB
7710
Not in Commercial Distribution
Atos Medical AB
Provox FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the valve closed during speech.
Device Characteristics
MR Unsafe | |
No | |
No | |
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? |
---|---|---|---|---|
36071 | Tracheostomy tube speech valve |
A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWL | Prosthesis, Laryngeal (Taub) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K022125 | 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
64e92b84-3c9a-4787-9676-6b01f00e6cb7
August 23, 2018
4
September 11, 2016
August 23, 2018
4
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