Provox Life Standard Experience Oval 8066

GUDID 07331791017018

Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy

Atos Medical AB

Removable ambulatory appliance skin-adherent patch

• Primary Device ID: 07331791017018
• NIH Device Record Key: fea771b4-8cbc-4c49-8c13-61b780b2fc13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox Life Standard Experience Oval
• Version Model Number: 8066
• Catalog Number: 8066
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791015663 [Primary]
GS1	07331791017018 [Unit of Use]
GS1	07331791017506 [Package]; Contains: 07331791015663; Package: Shipper Box [72 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-11-25
• Device Publish Date: 2022-11-29

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.