FLYp

GUDID 00869112000168

Vibrating mesh nebulizer

CONVEXITY SCIENTIFIC LLC

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• Primary Device ID: 00869112000168
• NIH Device Record Key: 3b628db4-dcbc-43df-900b-579c93a38263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLYp
• Version Model Number: 0002
• Company DUNS: 081072216
• Company Name: CONVEXITY SCIENTIFIC LLC
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com
• Phone: 860-810-7918
• Email: jon.wojculewicz@wellinks.com

Operating and Storage Conditions

• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869112000168 [Primary]
GS1	10869112000110 [Package]; Package: Case [48 Units]; In Commercial Distribution
GS1	10869112000165 [Package]; Package: Inner Pack [6 Units]; In Commercial Distribution

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [FLYp]

• 00869112000106: Vibrating mesh nebulizer
• 00869112000175: Hypersoniq PDA
• 00869112000168: Vibrating mesh nebulizer