FOX MOBILE 08RS2000

GUDID 05056143200017

The FOX MOBILE Nebulizer Head is part of the FOX MOBILE Inhalation Set.

VECTURA GROUP PLC

Nebulizing system, non-heated

• Primary Device ID: 05056143200017
• NIH Device Record Key: 0580f83f-7fb6-4b86-9f44-ea870c109595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOX MOBILE
• Version Model Number: FOX MOBILE Nebuliser Head
• Catalog Number: 08RS2000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056143200017 [Primary]

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.