Provox® XtraFlange™ 7276

GUDID 07331791006937

Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It p

Atos Medical AB

Tracheoesophageal speech valve, indwelling, sterile

• Primary Device ID: 07331791006937
• NIH Device Record Key: 806722a5-32a7-4508-8a45-32e180e0464a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® XtraFlange™
• Version Model Number: 20 Fr
• Catalog Number: 7276
• 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: false
• Device Combination Product: false
• 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

• Lumen/Inner Diameter: 6.6 Millimeter

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791006937 [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: true

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® XtraFlange™]

• 07331791006944: Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal
• 07331791006937: Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal
• 07331791006920: Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal