Provox® FreeHands FlexiVoice™ Set 7760

GUDID 07331791008283

The Provox FreeHands FlexiVoice consists of two parts assembled together, a speaking valve for single patient use and a disposable HME cassette. The s

Atos Medical AB

Tracheostomy tube speech valve

• Primary Device ID: 07331791008283
• NIH Device Record Key: 464457e5-f0b2-48e0-b592-eaa2e6223657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox® FreeHands FlexiVoice™ Set
• Version Model Number: 7760
• Catalog Number: 7760
• 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: true
• OTC Over-The-Counter: false

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
• 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

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
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791008283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141380

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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• 07331791016950 - Provox Life Home HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791016967 - Provox Life Energy HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
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