Provox® ActiValve® 7163

GUDID 07331791000607

The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blue ring sits inside the prosthesis, adding stability an

Atos Medical AB

Tracheoesophageal speech valve, indwelling, non-sterile

• Primary Device ID: 07331791000607
• NIH Device Record Key: b0513974-f9a0-4353-98b2-b3ecd24997c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® ActiValve®
• Version Model Number: Strong
• Catalog Number: 7163
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 10 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791000607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092593

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® ActiValve®]

• 07331791000669: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000652: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000645: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000638: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000621: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000614: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000607: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000591: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000584: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000577: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000560: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000553: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000546: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000539: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu
• 07331791000522: The Provox ActiValve voice prosthesis has a one-way valve and two retention flanges. A rigid blu