AKITA JET

GUDID 05056143200154

The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use.

VECTURA GROUP PLC

Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 05056143200154
• NIH Device Record Key: 700746d9-f0ba-4aee-8625-5aa8e08aae7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AKITA JET
• Version Model Number: AKITA JET Inhalation System
• 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: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com
• Phone: +498989796969
• Email: info@akita-jet.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056143200154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090730

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: 2017-06-27

Devices Manufactured by VECTURA GROUP PLC

• 05056143200055 - FOX MOBILE: 2019-09-17 The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and consists of following components: Nebuli
• 05056143200000 - FOX MOBILE: 2019-05-29 The Nebuliser Mouthpiece is part of the FOX MOBILE Inhalation Set.
• 05056143200017 - FOX MOBILE: 2019-05-29 The FOX MOBILE Nebulizer Head is part of the FOX MOBILE Inhalation Set.
• 05056143200024 - FOX MOBILE: 2019-05-29 The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
• 05056143200031 - FOX MOBILE: 2019-05-29 The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions
• 05056143200093 - N/A: 2019-05-29 Nebuliser handset in printed polyethylene bag
• 05056143200109 - N/A: 2019-05-29 Set of 10 nebuliser Sets and 10 Noseclips
• 05056143200116 - N/A: 2019-05-29 Set of 5 Bulk Pack in one shipment box