AccessGUDID - DEVICE: Provox LaryButton 12/18 (07331791002731)

GUDID

Device Identifier (DI) Information

Brand Name: Provox LaryButton 12/18
Version or Model: 7685
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7685
Company Name: Atos Medical AB

Primary DI Number: 07331791002731
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox LaryButton is a self-retaining holder for devices in the Provox HME system intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox LaryButton is intended for single patient use.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14093	Tracheostoma button	A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. 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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 12.0 Millimeter
Length: 18 Millimeter

Device Record Status

Public Device Record Key: 7c556b84-5892-42fd-a78a-ce28276d30b0
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: July 08, 2022