FastLoad™ CT Syringe Pack with spike 017345

GUDID 37630039300310

Bracco Injeneering SA

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 37630039300310
• NIH Device Record Key: 7a9d97dd-c607-4e00-81cb-6e3541af712e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastLoad™ CT Syringe Pack with spike
• Version Model Number: 017345
• Catalog Number: 017345
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• Phone: +41216236030
• Email: maud.giorgi@bracco.com
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment
• Special Storage Condition, Specify: Between 0 and 0 *Dry Environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	17630039300316 [Primary]
GS1	37630039300310 [Package]; Contains: 17630039300316; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933846

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-20

Devices Manufactured by Bracco Injeneering SA

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• 17630039302037 - Injector Head: 2024-05-06
• 17630039301627 - FastLoad™ MR Syringe Pack: 2024-04-16
• 37630039301980 - IV Pole: 2024-03-11
• 37630039301997 - Floor Stand: 2024-03-11
• 47630039301949 - EmpowerCTA+ Injector System: 2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 47630039302014 - EmpowerCTA+ Injector System: 2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
• 37630039301713 - Patient Set: 2022-01-24 Patient Set DEHT to be used with CT Exprès injectors