N/A 01VB0103

GUDID 05056143200123

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: 05056143200123
• NIH Device Record Key: 17c4da77-f2c1-4f83-9880-239cbd7c7e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: Nebuliser Tube System
• Catalog Number: 01VB0103
• Company DUNS: 536137748
• Company Name: VECTURA GROUP PLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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 Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• 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
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056143200123 [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

On-Brand Devices [N/A]

• 05056143200451: Nebuliser handset in printed polyethylene bag
• 05056143200123: Nebuliser Tube System
• 05056143200116: Set of 5 Bulk Pack in one shipment box
• 05056143200109: Set of 10 nebuliser Sets and 10 Noseclips
• 05056143200093: Nebuliser handset in printed polyethylene bag