DEVICE: Provox Life LaryTube 9/36 Fenestrated (07331791013706)
Device Identifier (DI) Information
Provox Life LaryTube 9/36 Fenestrated
7431
In Commercial Distribution
7431
Atos Medical AB
7431
In Commercial Distribution
7431
Atos Medical AB
Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.
Fenestrated model – made for voice prosthesis users. Can be attached with a Provox TubeHolder or Provox LaryClips.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
38792 | Tracheostomy tube, non-reinforced, non-customized, reusable |
A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KAC | Tube, Laryngectomy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 42 Degrees Celsius |
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight. |
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 10.5 Millimeter |
Outer Diameter: 13.5 Millimeter |
Length: 36 Millimeter |
Device Record Status
c1201e4d-55b5-402f-b5fc-0014d71921e2
November 29, 2024
3
July 07, 2022
November 29, 2024
3
July 07, 2022
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