FOX MOBILE 08RS5000

GUDID 05056143200024

The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.

VECTURA GROUP PLC

Nebulizing system, non-heated

• Primary Device ID: 05056143200024
• NIH Device Record Key: 30cca84c-72db-4917-9393-9fbc643422b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOX MOBILE
• Version Model Number: FOX MOBILE Base Unit
• Catalog Number: 08RS5000
• Company DUNS: 536137748
• Company Name: VECTURA GROUP PLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +498989796969
• Email: fox.mobile@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com
• Phone: +498989796969
• Email: regulatory@vectura.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056143200024 [Primary]
GS1	05056143202035 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142059

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2019-05-29
• Device Publish Date: 2017-05-05

On-Brand Devices [FOX MOBILE]

• 05056143200055: The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and consists
• 05056143200031: The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalatio
• 05056143200024: The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
• 05056143200017: The FOX MOBILE Nebulizer Head is part of the FOX MOBILE Inhalation Set.
• 05056143200000: The Nebuliser Mouthpiece is part of the FOX MOBILE Inhalation Set.