Provox® Vega™ Plug 8129

GUDID 07331791005954

The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the open

Atos Medical AB

Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved Tracheoesophageal speech valve occluder, non-valved

• Primary Device ID: 07331791005954
• NIH Device Record Key: 056a9413-d7dc-44fe-bf99-8e6d94846cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® Vega™ Plug
• Version Model Number: 20 Fr
• Catalog Number: 8129
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com
• Phone: +4641519800
• Email: info@atosmedical.com

Device Dimensions

• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter
• Outer Diameter: 5.9 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791005954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940638

FDA Product Code

• EWL: Prosthesis, Laryngeal (Taub)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

On-Brand Devices [Provox® Vega™ Plug]

• 07331791005961: The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega
• 07331791005954: The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega
• 07331791005947: The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega