FLAEM Rhino Clear Sprint DR12P00

GUDID 08018294012793

Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose

FLAEM NUOVA SPA

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• Primary Device ID: 08018294012793
• NIH Device Record Key: 01635ed0-2d36-4ea4-8a03-0dd03e982475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLAEM Rhino Clear Sprint
• Version Model Number: P0709EM
• Catalog Number: DR12P00
• Company DUNS: 431208297
• Company Name: FLAEM NUOVA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it
• Phone: 0309910168
• Email: regulatory@flaemnuova.it

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 69 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08018294012793 [Primary]

FDA Product Code

• JPW: Pump, Nebulizer, Electrically Powered

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: 2020-07-20
• Device Publish Date: 2020-07-10