AccessGUDID - DEVICE: Provox® Plug (07331791000782)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® Plug
Version or Model: 7205
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Atos Medical AB

Primary DI Number: 07331791000782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: The Provox Plug is a first-aid tool for temporarily stopping leakage through the voice prosthesis. The device is inserted into the opening of the Provox voice prosthesis. The medallion end can be taped to the skin if desired.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Tracheoesophageal speech valve occluder, non-valved	A non-sterile device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Tracheoesophageal speech valve occluder, non-valved

A non-sterile device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable device.

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 [?]
K940638	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

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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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 84e4afec-75b8-498a-8d1b-ef9b0a81cf56
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 11, 2016