Provox® ActiValve®

Basic Information

• Brand Name: Provox® ActiValve®
• Primary DI: 07331791000652
• Version / Model: XtraStrong
• Catalog Number: 7168
• Company Name: Atos Medical AB
• Labeler DUNS: 355470923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8269b63e-bf82-466f-a900-bc136b8cb63b

Device Description

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWL	Prosthesis, Laryngeal (Taub)	Ear, Nose, Throat	874.3730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07331791000652	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092593	000

Device Sizes

Type	Value	Unit	Text
Length	10	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 36 – 108 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.