Provox XtraFlow & XtraMoist HME (5+5 pcs) 8229

GUDID 07331791010286

The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

Atos Medical AB

Tracheostoma protective filter

• Primary Device ID: 07331791010286
• NIH Device Record Key: 4ce02239-3fa9-44a5-8351-81a81f025d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provox XtraFlow & XtraMoist HME (5+5 pcs)
• Version Model Number: 8229
• Catalog Number: 8229
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791010286 [Primary]

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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: 2022-12-02
• Device Publish Date: 2022-11-24

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): 2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices