Provox® FreeHands HME® Speech Valve Membrane Mediu 7714

GUDID 07331791002922

The Membrane temporarily closes the Freehands HME Speech Valve, allowing the patient to produce voice without manually occluding the stoma.

Atos Medical AB

Tracheostomy tube speech valve

• Primary Device ID: 07331791002922
• NIH Device Record Key: c23698d6-6861-4d71-adb0-eb8b44edcdff
• Commercial Distribution Discontinuation: 2016-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Provox® FreeHands HME® Speech Valve Membrane Mediu
• Version Model Number: Medium
• Catalog Number: 7714
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

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	07331791002922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022125

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: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-09-11

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