Provox LaryButton Sizer Kit 7690

GUDID 07331791002779

The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual use.

Atos Medical AB

Tracheostoma button

• Primary Device ID: 07331791002779
• NIH Device Record Key: 11462e8a-8111-4046-8688-94845f7b6dbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox LaryButton Sizer Kit
• Version Model Number: 7690
• Catalog Number: 7690
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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
• 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

• 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. 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 dry. Keep away from sunlight
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791002779 [Primary]

FDA Product Code

• KAC: Tube, Laryngectomy

Sterilization

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

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

[07331791002779]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-05
• Device Publish Date: 2022-11-25

Devices Manufactured by Atos Medical AB

• 07331791016905 - Provox Adhesive OptiDerm Round: 2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016929 - Provox XtraBase Adhesive: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016899 - Provox Adhesive FlexiDerm Plus: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016912 - Provox Adhesive OptiDerm Plus: 2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791016943 - Provox Life Go HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 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.
• 07331791016974 - Provox Life Protect HME: 2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.