AccessGUDID - DEVICE: Provox® ActiValve® (07331791000669)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® ActiValve®
Version or Model: XtraStrong
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7169
Company Name: Atos Medical AB

Primary DI Number: 07331791000669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
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

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Product Code	Product Code Name
EWL	Prosthesis, Laryngeal (Taub)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092593	000

Device Exempt from Premarket Submission: No 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
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: 12.5 Millimeter

Device Record Status

Public Device Record Key: 310796a0-ed5d-4f5f-93da-239330fa2291
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 11, 2016