Provox Life Comfort Adhesive Oval 8403

GUDID 07331791181238

Atos Medical AB

Removable ambulatory appliance skin-adherent patch

• Primary Device ID: 07331791181238
• NIH Device Record Key: 0030b551-adae-4590-8046-cd9e6cfdb9e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox Life Comfort Adhesive Oval
• Version Model Number: 8403
• Catalog Number: 8403
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791181214 [Unit of Use]
GS1	07331791181221 [Primary]
GS1	07331791181238 [Package]; Contains: 07331791181221; Package: Shipper Box [36 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by Atos Medical AB

• 07331791181238 - Provox Life Comfort Adhesive Oval: 2026-01-26
• 07331791181238 - Provox Life Comfort Adhesive Oval: 2026-01-26
• 07331791181276 - Provox Life Comfort Experience Oval: 2026-01-26
• 07331791181153 - Provox Life Oxygen (10 pcs): 2025-12-24
• 07331791181160 - Provox Life Oxygen (30 pcs): 2025-12-24
• 07331791181177 - Provox Dilator 17: 2025-07-09
• 07331791181184 - Provox Dilator 20: 2025-07-09
• 07331791181191 - Provox Dilator: 2025-02-17
• 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