FastLoad™ CTA Dual Syringe Pack 017346

GUDID 37630039300327

Bracco Injeneering SA

Intravenous administration set

• Primary Device ID: 37630039300327
• NIH Device Record Key: 49cf5165-556d-47e2-bae1-adfb179a5ea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastLoad™ CTA Dual Syringe Pack
• Version Model Number: 017346
• Catalog Number: 017346
• 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	17630039300323 [Primary]
GS1	37630039300327 [Package]; Contains: 17630039300323; Package: Box [20 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

On-Brand Devices [FastLoad™ CTA Dual Syringe Pack]

• 17630039300880: 017354
• 37630039300327: 017346