Injector 102410

GUDID 37630039300822

Bracco Injeneering SA

CT contrast medium injection system, line-powered, stationary

• Primary Device ID: 37630039300822
• NIH Device Record Key: 2b74c38b-268b-4242-8a5c-039c208c6906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Injector
• Version Model Number: 102410
• Catalog Number: 102410
• Company DUNS: 482489007
• Company Name: Bracco Injeneering SA
• 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: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Dry environment
• Handling Environment Atmospheric Pressure: Between 10 KiloPascal and 110 KiloPascal
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630039300743 [Previous]
GS1	17630039300798 [Primary]
GS1	37630039300822 [Package]; Contains: 17630039300798; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• DSB: Plethysmograph, Impedance

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-26

On-Brand Devices [Injector]

• 37630039300822: 102410
• 37630039300747: 102410
• 37630039301454: 102410