Provox FlexiDerm Oval (3pcs) 8235

GUDID 07331791010316

The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.

Atos Medical AB

Removable ambulatory appliance skin-adherent patch

• Primary Device ID: 07331791010316
• NIH Device Record Key: 517e0679-89cb-461c-acac-b771a6495751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox FlexiDerm Oval (3pcs)
• Version Model Number: 8235
• Catalog Number: 8235
• Company DUNS: 355470923
• Company Name: Atos Medical AB
• Device Count: 3
• 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
• 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

• Handling Environment Temperature: Between 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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 2 Degrees Celsius and 42 Degrees Celsius
• 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	07331791010316 [Primary]
GS1	07331791016455 [Unit of Use]

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: 2
• Public Version Date: 2023-11-03
• Device Publish Date: 2022-12-08

Devices Manufactured by Atos Medical AB

• 07331791017209 - Provox Life Home HME Experience: 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791017216 - Provox Life Go HME Experience: 2024-07-01 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
• 07331791014901 - Freevent XtraCare Mini White: 2023-12-12 Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter in
• 07331791008023 - Provox StabiliBase (3pcs): 2023-11-03 The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. T
• 07331791009044 - Provox StabiliBase OptiDerm (3pcs): 2023-11-03 Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheosto
• 07331791010293 - Provox XtraBase (3pcs): 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791010309 - Provox FlexiDerm Round (3pcs): 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
• 07331791010316 - Provox FlexiDerm Oval (3pcs): 2023-11-03The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
• 07331791010316 - Provox FlexiDerm Oval (3pcs): 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices